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Healthy Adult Male

11
Pipeline Programs
7
Companies
11
Clinical Trials
3 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
11
0
0
0
0
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
150%
Small Molecule
150%
+ 9 programs with unclassified modality

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Otsuka
OtsukaJapan - Tokushima
4 programs
4
Brexpiprazole ODT 2mg with waterPhase 11 trial
OPC-34712Phase 11 trial
OPC-41061Phase 11 trial
OPC-61815 injectionPhase 11 trial
Active Trials
NCT03902574Completed21Est. Jun 2019
NCT02875080Completed18Est. Nov 2016
NCT02994394Completed84Est. Feb 2017
+1 more trials
Sunshine Biopharma
Sunshine BiopharmaQC - Varennes
2 programs
2
HEC-151 Injection and placeboPhase 11 trial
[14C]ClifutinibPhase 1Small Molecule1 trial
Active Trials
NCT07376200Recruiting81Est. Sep 2026
NCT07211165Completed6Est. Nov 2025
Biocad
BiocadRussia - St. Petersburg
1 program
1
AdalimumabPhase 1Monoclonal Antibody1 trial
Active Trials
NCT07181694Recruiting444Est. Nov 2025
GEn1E Lifesciences
GEn1E LifesciencesCA - Palo Alto
1 program
1
GEn-1124Phase 11 trial
Active Trials
NCT07185113Recruiting6Est. Dec 2025
Mediar Therapeutics
1 program
1
MTX-463Phase 11 trial
Active Trials
NCT07450521Completed8Est. Mar 2026
Astellas
AstellasChina - Shenyang
1 program
1
TRK-100STPPhase 11 trial
Active Trials
NCT01423435Completed36Est. Sep 2011
Vivozon
VivozonKorea - Gyeonggi
1 program
1
[14C]-VVZ-149Phase 11 trial
Active Trials
NCT04415645Completed6Est. Mar 2020

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Sunshine BiopharmaHEC-151 Injection and placebo
Mediar TherapeuticsMTX-463
GEn1E LifesciencesGEn-1124
Sunshine Biopharma[14C]Clifutinib
BiocadAdalimumab
OtsukaOPC-61815 injection
Vivozon[14C]-VVZ-149
OtsukaBrexpiprazole ODT 2mg with water
OtsukaOPC-41061
OtsukaOPC-34712
AstellasTRK-100STP

Clinical Trials (11)

Total enrollment: 728 patients across 11 trials

NCT07376200Sunshine BiopharmaHEC-151 Injection and placebo

Single-ascending Dose Study of HEC-151 Injection

Start: Feb 2026Est. completion: Sep 202681 patients
Phase 1Recruiting
NCT07450521Mediar TherapeuticsMTX-463

Evaluation of MTX-463 Administered Subcutaneously in Healthy Adult Males

Start: Feb 2026Est. completion: Mar 20268 patients
Phase 1Completed
NCT07185113GEn1E LifesciencesGEn-1124

A Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects

Start: Oct 2025Est. completion: Dec 20256 patients
Phase 1Recruiting
NCT07211165Sunshine Biopharma[14C]Clifutinib

Clinical Study on the Mass Balance of Clifutinib

Start: Sep 2025Est. completion: Nov 20256 patients
Phase 1Completed
NCT07181694BiocadAdalimumab

A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects

Start: Mar 2025Est. completion: Nov 2025444 patients
Phase 1Recruiting
NCT05439148OtsukaOPC-61815 injection

OPC-61815 in Healthy Chinese Male Subjects

Start: Jun 2022Est. completion: Sep 202218 patients
Phase 1Completed
NCT04415645Vivozon[14C]-VVZ-149

Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects

Start: Feb 2020Est. completion: Mar 20206 patients
Phase 1Completed
NCT03902574OtsukaBrexpiprazole ODT 2mg with water

Bioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mg

Start: Mar 2019Est. completion: Jun 201921 patients
Phase 1Completed
NCT02994394OtsukaOPC-41061

A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects

Start: Jan 2017Est. completion: Feb 201784 patients
Phase 1Completed
NCT02875080OtsukaOPC-34712

Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects

Start: Sep 2016Est. completion: Nov 201618 patients
Phase 1Completed
NCT01423435AstellasTRK-100STP

Study to Compare Pharmacokinetic Profiles of TRK-100STP in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males

Start: Aug 2011Est. completion: Sep 201136 patients
Phase 1Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

3 actively recruiting trials targeting 728 patients
7 companies competing in this space

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