Different Names of Participants in Phase I Clinical Trials
,
Abstract
Background: Clinical trials contribute to the generation of new knowledge and can lead to the discovery of novel treatments. By introducing more effective therapies, they can improve patients' quality of life and reduce the complications of diseases. For searching scientific resources in this context, one should focus on appropriate keywords, identify synonyms, related phrases, and academic terms in this field to expand the scope of the search. The first phase of clinical trials is the initial step in evaluating an investigational drug product in humans.
Conclusion: In this review, given the importance of Phase I clinical trials, we first address the different and common names of Phase I clinical trials and then provide examples of synonyms for "study participants." It is hoped that researchers can, by identifying synonyms and related academic phrases, more quickly and accurately find relevant scientific resources and produce more precise and clear scientific writing.
1. Eisenhauer E, O’dwyer P, Christian M, et al. Phase I clinical trial design in cancer drug development. J Clin Onc 2000; 18(3):684-.
2. Kandi V, Vadakedath S. Clinical trials and clinical research: a comprehensive review. Cureus 2023; 15(2): e35077.
3. Essink B, Chu L, Seger W, et al. The safety and immunogenicity of two Zika virus mRNA vaccine candidates in healthy flavivirus baseline seropositive and seronegative adults: the results of two randomised, placebo-controlled, dose-ranging, phase 1 clinical trials. Lancet Infect Dis 2023; 23(5):621-33.
4. Holmes C, Boche D, Wilkinson D, et al. Long-term effects of Aβ42 immunisation in Alzheimer's disease: follow-up of a randomised, placebo-controlled phase I trial. Lancet 2008; 372(9634):216-23.
5. Lewis L, Schary W, De S, et al. 603 A randomized, placebo-controlled, first in human phase I single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy male volunteers of the immunostimulant 7HP349. BMJ Specialist J 2022; 10(Suppl 2):A631.
6. Xu RH, Wei X, Zhang D, et al. A phase 1a dose-escalation, multicenter trial of anti-claudin 18.2 antibody drug conjugate CMG901 in patients with resistant/refractory solid tumors. Am Soc Clin Onc 2023.352.
7. Wang Y, Shi G, Wang X, et al. Preliminary evaluation of the safety and immunogenicity of a novel protein-based pneumococcal vaccine in healthy adults aged 18–49: A Phase Ia randomized, double blind, placebo-controlled clinical study. Vaccines 2024; 12(8):827.
8. Bruss J, Lister T, Gupta VK, et al. Single-and multiple-ascending-dose study of the safety, tolerability, and pharmacokinetics of the polymyxin derivative SPR206. Antimicrob Agents Chemother 2021; 65(10):10.1128/aac. 00739-21.
9. Fukuoka S, Hara H, Takahashi N, et al. Regorafenib plus nivolumab in patients with advanced gastric or colorectal cancer: an open-label, dose-escalation, and dose-expansion phase Ib trial (REGONIVO, EPOC1603). J Clin Onc 2020; 38(18):2053-61.
10. van der Ree MH, de Vree JM, Stelma F, et al. Safety, tolerability, and antiviral effect of RG-101 in patients with chronic hepatitis C: a phase 1B, double-blind, randomised controlled trial. Lancet. 2017; 389(10070):709-17.
11. Kim BS, Kim SJ, Yoon DH, et al. A novel PI3K γ/δ and DNA-PK triple inhibitor, BR101801, for r/r PTCL: a phase 1a/b, Multi-center, open-label clinical trial. Blood 2023; 142:1701.
12. Bang YJ, Golan T, Dahan L, et al. Ramucirumab and durvalumab for previously treated, advanced non–small-cell lung cancer, gastric/gastro-oesophageal junction adenocarcinoma, or hepatocellular carcinoma: An open-label, phase Ia/b study (JVDJ). Eur J Cancer 2020; 137:272-84.
13. Ishihara M, Tono Y, Miyahara Y, et al. First-in-human phase I clinical trial of the NY-ESO-1 protein cancer vaccine with NOD2 and TLR9 stimulants in patients with NY-ESO-1-expressing refractory solid tumors. Cancer Immunology, Immunotherapy 2020; 69:663-75.
14. Yap TA, Yan L, Patnaik A, et al. First-in-man clinical trial of the oral pan-AKT inhibitor MK-2206 in patients with advanced solid tumors. J Clin Onc 2011; 29(35):4688-95.
15. Lanzoni G, Linetsky E, Correa D, et al. Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial. Stem Cells Trans Med 2021; 10(5):660-73.
16. Jain R, Handorf E, Khare V, et al. Impact of baseline nutrition and exercise status on toxicity and outcomes in phase I and II oncology clinical trial participants. Oncologist 2020; 25(2):161-9.
17. Alpers DH, Lewis JH, Hunt CM, et al. Clinical pattern of tolvaptan-associated liver injury in trial participants with autosomal dominant polycystic kidney disease (ADPKD): an analysis of pivotal clinical trials. Am J Kidney Dis 2023; 81(3):281-93.
18. Luca W, Foster K, McClure K, et al. A Phase 1 single-ascending-dose trial in healthy volunteers to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of intravenous pnt001, a novel mid-domain tau antibody targeting cis-pT231 tau. J Prevention Alzheimer's Dis 2024; 11(2):366-74.
19. Holscher HD, Bauer LL, Gourineni V, et al. Agave inulin supplementation affects the fecal microbiota of healthy adults participating in a randomized, double-blind, placebo-controlled, crossover trial. J Nutrition 2015; 145(9):2025-32.
20. Williams DD, Peng B, Bailey CK, et al. Effects of food and antacids on the pharmacokinetics of eltrombopag in healthy adult subjects: two single-dose, open-label, randomized-sequence, crossover studies. Clin Therapeutics 2009; 31(4):764-76.
21. Cheng JY, Moline M, Zammit GK, et al. Respiratory safety of lemborexant in healthy subjects: a single-dose, randomized, double-blind, placebo-controlled, crossover study. Clin Drug Investigation 2021; 41:449-57.
22. Meola TR, Abuhelwa AY, Joyce P, et al. A safety, tolerability, and pharmacokinetic study of a novel simvastatin silica-lipid hybrid formulation in healthy male participants. Drug Delivery Trans Res 2021; 11:1261-72.
23. Ingelheim B. A Study in Healthy People to Test Whether BI 730357 Affects How 4 Other Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Taken up in the Body; ClinicalTrials.gov ID: NCT04590937. 2023 [updated 2023-09-06. Available from: https://clinicaltrials.gov/study/NCT04590937?cond=NCT04590937&rank=1#collaborators-and-investigators.
24. Ingelheim B. A Study in Healthy Men and Women Who Are Either Between 18 - 45 Years or Between 65 - 80 Years to Test How Different Doses of BI 474121 Are Tolerated; ClinicalTrials.gov: ID NCT04537897. 2024 [updated 2024-03-08. Available from: https://clinicaltrials.gov/study/NCT04537897?cond=NCT04537897&rank=1.
25. Lilly E. A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants; ClinicalTrials.gov ID: NCT04172987. 2023 [updated 2023-03-27. Available from: https://clinicaltrials.gov/study/NCT04172987?cond=NCT04172987&rank=1.
26. BeiGene. The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males; ClinicalTrials.gov ID: NCT04470908. 2024 [updated 2024-10-26. Available from: https://clinicaltrials.gov/study/NCT04470908?cond=NCT04470908&rank=1#collaborators-and-investigators.
27. Therapeutics C. Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of CT1812 in Healthy Adult Male Subjects (COG0108); ClinicalTrials.gov ID NCT05225389. 2023 [updated 2023-07-21. Available from: https://clinicaltrials.gov/study/ NCT05225389?cond=NCT05225389&rank=1.
28. Qureshi IA, Tirucherai G, Ahlijanian MK, et al. A randomized, single ascending dose study of intravenous BIIB092 in healthy participants. Alzheimer's & Dementia: Transl Res Clin Interv 2018; 4:746-55.
29. SRL UB. A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants; ClinicalTrials.gov: ID NCT05315947. 2024 [updated 2024-01-05. Available from: https://clinicaltrials.gov/study/NCT05315947?cond=NCT05315947&rank=1.
30. Ingelheim B. A Trial in Healthy Chinese Volunteers to Test How Different Doses of BI 655130 Are Taken up in the Body 2023 [updated 2023-08-07. Available from: https://clinicaltrials.gov/study/NCT04390568?cond=%20NCT04390568&rank=1.
31. Zhejiang Genfleet Therapeutics Co. L. A Study of GFH018 in Patients With Advanced Solid Tumors; ClinicalTrials.gov ID: NCT05051241. 2024 [updated 2024-03-01. Available from: https://clinicaltrials.gov/study/NCT05051241?cond=NCT05051241&rank=1.
32. LLC MSD. A Study of MK-8189 in Participants With Schizophrenia (MK-8189-014); ClinicalTrials.gov: ID NCT05406440. 2024 [updated 2024-07-25. Available from: https://clinicaltrials.gov/study/NCT05406440?cond=NCT05406440&rank=1.
33. Denkert C, Seither F, Schneeweiss A, et al. Clinical and molecular characteristics of HER2-low-positive breast cancer: pooled analysis of individual patient data from four prospective, neoadjuvant clinical trials. Lancet Onc 2021; 22(8):1151-61.
34. Salvarani C, Dolci G, Massari M, et al. Effect of tocilizumab vs standard care on clinical worsening in patients hospitalized with COVID-19 pneumonia: a randomized clinical trial. JAMA Internal Med 2021; 181(1):24-31.
35. Limited TTS. Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia; ClinicalTrials.gov ID NCT06135675. 2024 [updated 2024-05-10. Available from: https://clinicaltrials.gov/study/NCT06135675?cond=NCT06135675&rank=1.
36. Nagendrababu V, Duncan H, Pulikkotil S, Dummer P. Glossary for randomized clinical trials. International Endodontic Journal. 2021;54(3):354-65.
37. Österdahl M, Kocturk T, Koochek A, et al. Effects of a short-term intervention with a paleolithic diet in healthy volunteers. Eur J Clin Nutrition 2008; 62(5):682-5.
38. Grode L, Ganoza CA, Brohm C, et al. Safety and immunogenicity of the recombinant BCG vaccine VPM1002 in a phase 1 open-label randomized clinical trial. Vaccine 2013; 31(9):1340-8.
39. Alexion Pharmaceuticals I. Study of ALXN1820 in Healthy Adult Participants A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1820 in Healthy Participants; ClinicalTrials.gov Identifier: NCT04631562 2024 [updated 2024-08-20. Available from: https://clinicaltrials.gov/study/NCT04631562?cond=NCT04631562&rank=1.
40. Corporation MTP. Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study); ClinicalTrials.gov ID NCT05342597. 2024 [updated 2024-01-05. Available from: https://clinicaltrials.gov/study/NCT05342597?cond=NCT05342597&rank=1.
41. Ltd. LPG. A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects; ClinicalTrials.gov ID: NCT06556966. 2024 [updated 2024-08-16. Available from: https://clinicaltrials.gov/study/NCT06556966?cond=NCT06556966&rank=1.
42. Millennium Pharmaceuticals I. Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants; ClinicalTrials.gov ID: NCT04454918. 2022 [updated 2022-03-07. Available from: https://clinicaltrials.gov/study/NCT04454918?cond=NCT04454918&rank=1.
43. Pharmaceuticals N. Safety, Tolerability, and Pharmacokinetics of XXB750 in Healthy Participants; ClinicalTrials.gov ID NCT06558097. 2024 [updated 2024-08-16. Available from: https://clinicaltrials.gov/study/NCT06558097?cond=NCT06558097&rank=1.
44. Naviaux RK, Curtis B, Li K, et al. Low‐dose suramin in autism spectrum disorder: a small, phase I/II, randomized clinical trial. Ann Clin Trans Neur 2017; 4(7):491-505.
45. Mathieu C, Wiedeman A, Cerosaletti K, et al. A first-in-human, open-label Phase 1b and a randomised, double-blind Phase 2a clinical trial in recent-onset type 1 diabetes with AG019 as monotherapy and in combination with teplizumab. Diabetologia 2024; 67(1):27-41.
46. Koene S, Spaans E, Van Bortel L, et al. KH176 under development for rare mitochondrial disease: a first in man randomized controlled clinical trial in healthy male volunteers. Orphanet J Rare Dis 2017; 12:1-12.
2. Kandi V, Vadakedath S. Clinical trials and clinical research: a comprehensive review. Cureus 2023; 15(2): e35077.
3. Essink B, Chu L, Seger W, et al. The safety and immunogenicity of two Zika virus mRNA vaccine candidates in healthy flavivirus baseline seropositive and seronegative adults: the results of two randomised, placebo-controlled, dose-ranging, phase 1 clinical trials. Lancet Infect Dis 2023; 23(5):621-33.
4. Holmes C, Boche D, Wilkinson D, et al. Long-term effects of Aβ42 immunisation in Alzheimer's disease: follow-up of a randomised, placebo-controlled phase I trial. Lancet 2008; 372(9634):216-23.
5. Lewis L, Schary W, De S, et al. 603 A randomized, placebo-controlled, first in human phase I single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy male volunteers of the immunostimulant 7HP349. BMJ Specialist J 2022; 10(Suppl 2):A631.
6. Xu RH, Wei X, Zhang D, et al. A phase 1a dose-escalation, multicenter trial of anti-claudin 18.2 antibody drug conjugate CMG901 in patients with resistant/refractory solid tumors. Am Soc Clin Onc 2023.352.
7. Wang Y, Shi G, Wang X, et al. Preliminary evaluation of the safety and immunogenicity of a novel protein-based pneumococcal vaccine in healthy adults aged 18–49: A Phase Ia randomized, double blind, placebo-controlled clinical study. Vaccines 2024; 12(8):827.
8. Bruss J, Lister T, Gupta VK, et al. Single-and multiple-ascending-dose study of the safety, tolerability, and pharmacokinetics of the polymyxin derivative SPR206. Antimicrob Agents Chemother 2021; 65(10):10.1128/aac. 00739-21.
9. Fukuoka S, Hara H, Takahashi N, et al. Regorafenib plus nivolumab in patients with advanced gastric or colorectal cancer: an open-label, dose-escalation, and dose-expansion phase Ib trial (REGONIVO, EPOC1603). J Clin Onc 2020; 38(18):2053-61.
10. van der Ree MH, de Vree JM, Stelma F, et al. Safety, tolerability, and antiviral effect of RG-101 in patients with chronic hepatitis C: a phase 1B, double-blind, randomised controlled trial. Lancet. 2017; 389(10070):709-17.
11. Kim BS, Kim SJ, Yoon DH, et al. A novel PI3K γ/δ and DNA-PK triple inhibitor, BR101801, for r/r PTCL: a phase 1a/b, Multi-center, open-label clinical trial. Blood 2023; 142:1701.
12. Bang YJ, Golan T, Dahan L, et al. Ramucirumab and durvalumab for previously treated, advanced non–small-cell lung cancer, gastric/gastro-oesophageal junction adenocarcinoma, or hepatocellular carcinoma: An open-label, phase Ia/b study (JVDJ). Eur J Cancer 2020; 137:272-84.
13. Ishihara M, Tono Y, Miyahara Y, et al. First-in-human phase I clinical trial of the NY-ESO-1 protein cancer vaccine with NOD2 and TLR9 stimulants in patients with NY-ESO-1-expressing refractory solid tumors. Cancer Immunology, Immunotherapy 2020; 69:663-75.
14. Yap TA, Yan L, Patnaik A, et al. First-in-man clinical trial of the oral pan-AKT inhibitor MK-2206 in patients with advanced solid tumors. J Clin Onc 2011; 29(35):4688-95.
15. Lanzoni G, Linetsky E, Correa D, et al. Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial. Stem Cells Trans Med 2021; 10(5):660-73.
16. Jain R, Handorf E, Khare V, et al. Impact of baseline nutrition and exercise status on toxicity and outcomes in phase I and II oncology clinical trial participants. Oncologist 2020; 25(2):161-9.
17. Alpers DH, Lewis JH, Hunt CM, et al. Clinical pattern of tolvaptan-associated liver injury in trial participants with autosomal dominant polycystic kidney disease (ADPKD): an analysis of pivotal clinical trials. Am J Kidney Dis 2023; 81(3):281-93.
18. Luca W, Foster K, McClure K, et al. A Phase 1 single-ascending-dose trial in healthy volunteers to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of intravenous pnt001, a novel mid-domain tau antibody targeting cis-pT231 tau. J Prevention Alzheimer's Dis 2024; 11(2):366-74.
19. Holscher HD, Bauer LL, Gourineni V, et al. Agave inulin supplementation affects the fecal microbiota of healthy adults participating in a randomized, double-blind, placebo-controlled, crossover trial. J Nutrition 2015; 145(9):2025-32.
20. Williams DD, Peng B, Bailey CK, et al. Effects of food and antacids on the pharmacokinetics of eltrombopag in healthy adult subjects: two single-dose, open-label, randomized-sequence, crossover studies. Clin Therapeutics 2009; 31(4):764-76.
21. Cheng JY, Moline M, Zammit GK, et al. Respiratory safety of lemborexant in healthy subjects: a single-dose, randomized, double-blind, placebo-controlled, crossover study. Clin Drug Investigation 2021; 41:449-57.
22. Meola TR, Abuhelwa AY, Joyce P, et al. A safety, tolerability, and pharmacokinetic study of a novel simvastatin silica-lipid hybrid formulation in healthy male participants. Drug Delivery Trans Res 2021; 11:1261-72.
23. Ingelheim B. A Study in Healthy People to Test Whether BI 730357 Affects How 4 Other Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Taken up in the Body; ClinicalTrials.gov ID: NCT04590937. 2023 [updated 2023-09-06. Available from: https://clinicaltrials.gov/study/NCT04590937?cond=NCT04590937&rank=1#collaborators-and-investigators.
24. Ingelheim B. A Study in Healthy Men and Women Who Are Either Between 18 - 45 Years or Between 65 - 80 Years to Test How Different Doses of BI 474121 Are Tolerated; ClinicalTrials.gov: ID NCT04537897. 2024 [updated 2024-03-08. Available from: https://clinicaltrials.gov/study/NCT04537897?cond=NCT04537897&rank=1.
25. Lilly E. A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants; ClinicalTrials.gov ID: NCT04172987. 2023 [updated 2023-03-27. Available from: https://clinicaltrials.gov/study/NCT04172987?cond=NCT04172987&rank=1.
26. BeiGene. The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males; ClinicalTrials.gov ID: NCT04470908. 2024 [updated 2024-10-26. Available from: https://clinicaltrials.gov/study/NCT04470908?cond=NCT04470908&rank=1#collaborators-and-investigators.
27. Therapeutics C. Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of CT1812 in Healthy Adult Male Subjects (COG0108); ClinicalTrials.gov ID NCT05225389. 2023 [updated 2023-07-21. Available from: https://clinicaltrials.gov/study/ NCT05225389?cond=NCT05225389&rank=1.
28. Qureshi IA, Tirucherai G, Ahlijanian MK, et al. A randomized, single ascending dose study of intravenous BIIB092 in healthy participants. Alzheimer's & Dementia: Transl Res Clin Interv 2018; 4:746-55.
29. SRL UB. A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants; ClinicalTrials.gov: ID NCT05315947. 2024 [updated 2024-01-05. Available from: https://clinicaltrials.gov/study/NCT05315947?cond=NCT05315947&rank=1.
30. Ingelheim B. A Trial in Healthy Chinese Volunteers to Test How Different Doses of BI 655130 Are Taken up in the Body 2023 [updated 2023-08-07. Available from: https://clinicaltrials.gov/study/NCT04390568?cond=%20NCT04390568&rank=1.
31. Zhejiang Genfleet Therapeutics Co. L. A Study of GFH018 in Patients With Advanced Solid Tumors; ClinicalTrials.gov ID: NCT05051241. 2024 [updated 2024-03-01. Available from: https://clinicaltrials.gov/study/NCT05051241?cond=NCT05051241&rank=1.
32. LLC MSD. A Study of MK-8189 in Participants With Schizophrenia (MK-8189-014); ClinicalTrials.gov: ID NCT05406440. 2024 [updated 2024-07-25. Available from: https://clinicaltrials.gov/study/NCT05406440?cond=NCT05406440&rank=1.
33. Denkert C, Seither F, Schneeweiss A, et al. Clinical and molecular characteristics of HER2-low-positive breast cancer: pooled analysis of individual patient data from four prospective, neoadjuvant clinical trials. Lancet Onc 2021; 22(8):1151-61.
34. Salvarani C, Dolci G, Massari M, et al. Effect of tocilizumab vs standard care on clinical worsening in patients hospitalized with COVID-19 pneumonia: a randomized clinical trial. JAMA Internal Med 2021; 181(1):24-31.
35. Limited TTS. Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia; ClinicalTrials.gov ID NCT06135675. 2024 [updated 2024-05-10. Available from: https://clinicaltrials.gov/study/NCT06135675?cond=NCT06135675&rank=1.
36. Nagendrababu V, Duncan H, Pulikkotil S, Dummer P. Glossary for randomized clinical trials. International Endodontic Journal. 2021;54(3):354-65.
37. Österdahl M, Kocturk T, Koochek A, et al. Effects of a short-term intervention with a paleolithic diet in healthy volunteers. Eur J Clin Nutrition 2008; 62(5):682-5.
38. Grode L, Ganoza CA, Brohm C, et al. Safety and immunogenicity of the recombinant BCG vaccine VPM1002 in a phase 1 open-label randomized clinical trial. Vaccine 2013; 31(9):1340-8.
39. Alexion Pharmaceuticals I. Study of ALXN1820 in Healthy Adult Participants A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1820 in Healthy Participants; ClinicalTrials.gov Identifier: NCT04631562 2024 [updated 2024-08-20. Available from: https://clinicaltrials.gov/study/NCT04631562?cond=NCT04631562&rank=1.
40. Corporation MTP. Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study); ClinicalTrials.gov ID NCT05342597. 2024 [updated 2024-01-05. Available from: https://clinicaltrials.gov/study/NCT05342597?cond=NCT05342597&rank=1.
41. Ltd. LPG. A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects; ClinicalTrials.gov ID: NCT06556966. 2024 [updated 2024-08-16. Available from: https://clinicaltrials.gov/study/NCT06556966?cond=NCT06556966&rank=1.
42. Millennium Pharmaceuticals I. Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants; ClinicalTrials.gov ID: NCT04454918. 2022 [updated 2022-03-07. Available from: https://clinicaltrials.gov/study/NCT04454918?cond=NCT04454918&rank=1.
43. Pharmaceuticals N. Safety, Tolerability, and Pharmacokinetics of XXB750 in Healthy Participants; ClinicalTrials.gov ID NCT06558097. 2024 [updated 2024-08-16. Available from: https://clinicaltrials.gov/study/NCT06558097?cond=NCT06558097&rank=1.
44. Naviaux RK, Curtis B, Li K, et al. Low‐dose suramin in autism spectrum disorder: a small, phase I/II, randomized clinical trial. Ann Clin Trans Neur 2017; 4(7):491-505.
45. Mathieu C, Wiedeman A, Cerosaletti K, et al. A first-in-human, open-label Phase 1b and a randomised, double-blind Phase 2a clinical trial in recent-onset type 1 diabetes with AG019 as monotherapy and in combination with teplizumab. Diabetologia 2024; 67(1):27-41.
46. Koene S, Spaans E, Van Bortel L, et al. KH176 under development for rare mitochondrial disease: a first in man randomized controlled clinical trial in healthy male volunteers. Orphanet J Rare Dis 2017; 12:1-12.
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How to Cite
1.
Khosravi E, Sabet F, Ghazvini K. Different Names of Participants in Phase I Clinical Trials. J Med Bacteriol. 2026;14(1):73-81.
