Healthy Male Subjects Clinical Trial
Official title:
A Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel Group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
This study is a Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
This study is a pilot phase 1, randomized, double-blind, two-arm, parallel group, single-dose study, which is designed to evaluate the safety, immunogenicity, PK and PD of CT-P41 and EU-approved Prolia in healthy male subjects. Approximately 30 male subjects will be enrolled and randomly assigned to one of the two treatment arms in a 1:1 ratio. In each treatment group, all subjects will receive a single 60 mg dose of either CT P41 or EU-approved Prolia by subcutaneous injection via a PFS on Day 1, followed by 134 days of safety, immunogenicity, PK, and PD measurements. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05621447 -
A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects
|
Phase 1 | |
| Completed |
NCT02901366 -
Mass Balance Study of FYU-981
|
Phase 2 | |
| Not yet recruiting |
NCT01928563 -
Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine
|
Phase 1 | |
| Completed |
NCT05559554 -
A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT06111196 -
Compare the Pharmacokinetics and Safety of BAT3306 Injection Versus KEYTRUDA® Administered in Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT03317652 -
Effect of Sodium Nitroprusside on Cerebral Blood Flow
|
N/A | |
| Completed |
NCT04655872 -
Mass Balance of Oral [14C]TPN171H in Healthy Male Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT02609711 -
Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects
|
Phase 1 | |
| Withdrawn |
NCT02560363 -
A Study to Compare the Pharmacokinetics of Different Formulations of AZD9977 and the Influence of Food in Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT01261260 -
Effect of Uridine on GABA and High Energy Phosphate Levels in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT05072028 -
Mass Balance and Biotransformation Study of [14C]DBPR108 in Human
|
Phase 1 | |
| Completed |
NCT05446233 -
ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT05275010 -
A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System
|
Phase 1 | |
| Completed |
NCT04839744 -
A Comparative Study of TG103 Produced by Two Manufacturing Processes in Chinese Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT05792917 -
Bioequivalence Study of Tafolecimab Injections in Chinese Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT03576651 -
A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT04825431 -
Mass Balance Study of [14C] TAS-205 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01819779 -
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60)
|
Phase 1 | |
| Completed |
NCT05126784 -
AVT03 With Prolia in Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT04850638 -
Drug Interaction Between SHR4640 Tablets and Furosemide Tablets in Healthy Volunteers (Single Center, Single Arm, Open, Self-control)
|
Phase 1 |