Healthy Male Subjects Clinical Trial
Official title:
A Randomized, Double-blind, Single-dose, Parallel-group Design, 2 Arm Study Comparing the Pharmacokinetic, Pharmacodynamic, Safety, Tolerability, and Immunogenicity Profiles of AVT03 and Prolia® in Healthy Male Subjects
This study has been designed as a randomized, double-blind, single-dose, parallel-group study in healthy adult male subjects 28 years to 55 years old. The study will assess the PK, PD, safety, tolerability and immunogenicity of AVT03 compared to Prolia when administered as a single SC dose.
The study will consist of a 4 week screening period, a 252 day (36 weeks) treatment and assessment period, and an End of Study (EOS) visit on week 36 on Day 252. Subjects will undertake a screening visit between Day -28 and Day -1 to determine their eligibility for the study. On Day 1, eligible subjects will be randomized and will receive a single dose of AVT03 or Prolia as subcutaneous injection. ;
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 | |
Completed |
NCT04512872 -
A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy 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Withdrawn |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 |
NCT04850638 -
Drug Interaction Between SHR4640 Tablets and Furosemide Tablets in Healthy Volunteers (Single Center, Single Arm, Open, Self-control)
|
Phase 1 |