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Healthy Male Subjects

24
Pipeline Programs
23
Companies
30
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
23
0
1
0
0
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
467%
Monoclonal Antibody
233%
+ 30 programs with unclassified modality

Competitive Landscape

23 companies ranked by most advanced pipeline stage

Mochida Pharmaceutical
1 program
1
14C-FYU-981Phase 21 trial
Active Trials
NCT02901366Completed6Est. Jul 2018
Hanlim Pharm
Hanlim PharmKorea - Seoul
4 programs
4
Exforge tab. 10/160mgPhase 11 trial
Exforge tab. 10/160mgPhase 11 trial
Exforge tab. 10/160mgPhase 11 trial
Sevikar tab. 10/40mgPhase 11 trial
Active Trials
NCT01652339Completed40Est. Dec 2012
NCT03648333Completed27Est. Jun 2014
NCT01819779Completed53Est. Nov 2013
+1 more trials
Innovent Biologics
Innovent BiologicsChina - Jiangsu
3 programs
3
bevacizumab with new manufacturing process.Phase 11 trial
sintilimabPhase 1Monoclonal Antibody1 trial
tafolecimabPhase 1Monoclonal Antibody1 trial
Active Trials
NCT05005455Completed100Est. Jan 2022
NCT05337267Completed117Est. Jul 2023
NCT05792917Completed166Est. Aug 2023
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
2 programs
2
AZD5718 oral suspension crystalline formPhase 11 trial
SavolitinibPhase 1Small Molecule1 trial
Active Trials
NCT02632526Completed96Est. Aug 2016
NCT05888207Completed16Est. Aug 2023
Biocorp
BiocorpFrance - Issoire
2 programs
2
Filgrastim testPhase 11 trial
Recombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for InjectionPhase 11 trial
Active Trials
NCT01933971Completed102Est. Apr 2008
NCT06111196Completed59Est. Jun 2024
Taiho Pharma
Taiho PharmaJapan - Tokyo
2 programs
2
TAS-205, [14C]TAS-205Phase 11 trial
TAS-303, [14C]TAS-303Phase 11 trial
Active Trials
NCT04825431Completed6Est. May 2022
NCT05621447Completed6Est. Feb 2023
Sunshine Biopharma
Sunshine BiopharmaQC - Varennes
2 programs
2
[14C] Antaitavir HasophatePhase 11 trial
[14C] YiqibuvirPhase 1Small Molecule1 trial
Active Trials
NCT05446233Completed6Est. Jan 2023
NCT05998304Completed8Est. Sep 2023
Zeria Pharmaceutical
1 program
1
14C-Z-215Phase 11 trial
Active Trials
NCT02618629Completed6Est. Sep 2016
Alvotech
AlvotechLUXEMBOURG, Luxembourg
1 program
1
AVT03Phase 11 trial
Active Trials
NCT05126784Completed209Est. Oct 2023
Dong-A ST
Dong-A STKorea - Seoul
1 program
1
DapoxetinePhase 11 trial
Active Trials
NCT01928563Unknown24Est. Dec 2013
Nerviano Medical Sciences
1 program
1
Filgrastim testPhase 1
Pfizer
PfizerNEW YORK, NY
1 program
1
Oral PF-06700841 containing 14C microtracerPhase 11 trial
Active Trials
NCT03770039Completed6Est. Feb 2019
Bio-Thera Solutions
Bio-Thera SolutionsChina - Guangzhou
1 program
1
Recombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for InjectionPhase 1
Saniona
SanionaDenmark - Glostrup
1 program
1
Tesomet "High dose" in fasted conditionPhase 11 trial
Active Trials
NCT03286829Completed60Est. Feb 2018
Medica Corp
Medica CorpMA - Bedford
1 program
1
[14C]TPN171HPhase 11 trial
Active Trials
NCT04655872Completed6Est. Jan 2021
Celltrion
CelltrionKorea - Incheon
4 programs
CT-P41PHASE_11 trial
CT-P43PHASE_11 trial
CT-P52PHASE_11 trial
CT-P55PHASE_11 trial
Active Trials
NCT04512872Completed30Est. May 2021
NCT06951828Completed162Est. Dec 2025
NCT07367958Active Not Recruiting218Est. Jan 2027
+1 more trials
Parexel
ParexelMA - Boston
2 programs
SavolitinibPHASE_1Small Molecule
SavolitinibPHASE_1Small Molecule
RAPT Therapeutics
RAPT TherapeuticsSOUTH SAN FRANCISCO, CA
1 program
14C RPT193PHASE_11 trial
Active Trials
NCT06087978Completed7Est. Oct 2023
Enzene Biosciences
Enzene BiosciencesIndia - Pune
1 program
ENZ215PHASE_11 trial
Active Trials
NCT05245669Completed207Est. May 2024
Roche
RocheSTAVANGER NORWAY, Norway
1 program
Fixed-Dose Combination of Pertuzumab and Trastuzumab SCPHASE_1
Kyowa Hakko Kirin
Kyowa Hakko KirinCA - La Jolla
1 program
KW-6356PHASE_11 trial
Active Trials
NCT04147910Completed8Est. Oct 2019
Biogen
BiogenCAMBRIDGE, MA
1 program
[14C]-OmaveloxolonePHASE_11 trial
Active Trials
NCT03931590Completed8Est. May 2019
Vigonvita
VigonvitaChina - Suzhou
1 program
[14C]TPN171HPHASE_1

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Mochida Pharmaceutical14C-FYU-981
CelltrionCT-P52
CelltrionCT-P43
CelltrionCT-P55
BiocorpRecombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for Injection
Sunshine Biopharma[14C] Yiqibuvir
RAPT Therapeutics14C RPT193
AstraZenecaSavolitinib
Innovent Biologicstafolecimab
Sunshine Biopharma[14C] Antaitavir Hasophate
Taiho PharmaTAS-303, [14C]TAS-303
AlvotechAVT03
Innovent Biologicssintilimab
Enzene BiosciencesENZ215
Innovent Biologicsbevacizumab with new manufacturing process.

Showing 15 of 30 trials with date data

Clinical Trials (30)

Total enrollment: 1,963 patients across 30 trials

Mass Balance Study of FYU-981

Start: Sep 2016Est. completion: Jul 20186 patients
Phase 2Completed

A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P52 in Healthy Male Subjects

Start: Jan 2026Est. completion: Jan 2027218 patients
Phase 1Active Not Recruiting

A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects

Start: May 2025Est. completion: Dec 2025162 patients
Phase 1Completed

To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects

Start: Jan 2024Est. completion: Sep 2024172 patients
Phase 1Completed
NCT06111196BiocorpRecombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for Injection

Compare the Pharmacokinetics and Safety of BAT3306 Injection Versus KEYTRUDA® Administered in Healthy Male Subjects

Start: Nov 2023Est. completion: Jun 202459 patients
Phase 1Completed

ADME Study of [14C] Yiqibuvir in Healthy Male Subjects

Start: Aug 2023Est. completion: Sep 20238 patients
Phase 1Completed

Study of RPT193 in Healthy Adult Male Subjects

Start: Jul 2023Est. completion: Oct 20237 patients
Phase 1Completed

A Study to Assess the Effects of Fluvoxamine on Savolitinib Exposure in Healthy Male Subjects

Start: Jun 2023Est. completion: Aug 202316 patients
Phase 1Completed

Bioequivalence Study of Tafolecimab Injections in Chinese Healthy Male Volunteers

Start: Mar 2023Est. completion: Aug 2023166 patients
Phase 1Completed
NCT05446233Sunshine Biopharma[14C] Antaitavir Hasophate

ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects

Start: Nov 2022Est. completion: Jan 20236 patients
Phase 1Completed
NCT05621447Taiho PharmaTAS-303, [14C]TAS-303

A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects

Start: Sep 2022Est. completion: Feb 20236 patients
Phase 1Completed

AVT03 With Prolia in Healthy Male Subjects

Start: Jun 2022Est. completion: Oct 2023209 patients
Phase 1Completed

Phase I Study of Sintilimab in Healthy Chinese Male Subjects

Start: Apr 2022Est. completion: Jul 2023117 patients
Phase 1Completed

Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers

Start: Jan 2022Est. completion: May 2024207 patients
Phase 1Completed
NCT05005455Innovent Biologicsbevacizumab with new manufacturing process.

Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects

Start: Jul 2021Est. completion: Jan 2022100 patients
Phase 1Completed
NCT04825431Taiho PharmaTAS-205, [14C]TAS-205

Mass Balance Study of [14C] TAS-205 in Healthy Volunteers

Start: Mar 2021Est. completion: May 20226 patients
Phase 1Completed

Mass Balance of Oral [14C]TPN171H in Healthy Male Subjects

Start: Nov 2020Est. completion: Jan 20216 patients
Phase 1Completed

A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects

Start: Oct 2020Est. completion: May 202130 patients
Phase 1Completed

Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-KW-6356

Start: Aug 2019Est. completion: Oct 20198 patients
Phase 1Completed
NCT03931590Biogen[14C]-Omaveloxolone

A Human AME Study for Omaveloxolone

Start: Apr 2019Est. completion: May 20198 patients
Phase 1Completed
NCT03770039PfizerOral PF-06700841 containing 14C microtracer

Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects

Start: Dec 2018Est. completion: Feb 20196 patients
Phase 1Completed
NCT03286829SanionaTesomet "High dose" in fasted condition

Study to Investigate the Pharmacokinetic Profile

Start: Dec 2017Est. completion: Feb 201860 patients
Phase 1Completed
NCT02632526AstraZenecaAZD5718 oral suspension crystalline form

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Male Subjects

Start: Feb 2016Est. completion: Aug 201696 patients
Phase 1Completed

Mass Balance and Metabolism Study of 14C-Z-215

Start: Jan 2016Est. completion: Sep 20166 patients
Phase 1Completed
NCT02955498Hanlim PharmSevikar tab. 10/40mg

Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivikar Tab. 5/40 mg in Healthy Adult Male Subjects

Start: Apr 2014Est. completion: May 201432 patients
Phase 1Completed
NCT03648333Hanlim PharmExforge tab. 10/160mg

Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=27)

Start: Dec 2013Est. completion: Jun 201427 patients
Phase 1Completed

Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine

Start: Sep 2013Est. completion: Dec 201324 patients
Phase 1Unknown
NCT01819779Hanlim PharmExforge tab. 10/160mg

Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60)

Start: Mar 2013Est. completion: Nov 201353 patients
Phase 1Completed
NCT01652339Hanlim PharmExforge tab. 10/160mg

Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects

Start: Jul 2012Est. completion: Dec 201240 patients
Phase 1Completed
NCT01933971BiocorpFilgrastim test

Evaluation of Dose-response, Pharmacodynamic and Pharmacokinetic Bioequivalence of Filgrastim in Healthy Male Volunteers After Single and Multiple-dose Subcutaneous Administration of the Test Injectable Formulation BK0023 vs. Neupogen®

Start: Jun 2007Est. completion: Apr 2008102 patients
Phase 1Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

23 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.