Clinical Trials Logo
  1. Home
  2. Healthy Subject
  3. NCT06037395

Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects

Healthy Subject Clinical Trial

Official title:
A Randomized, Double-blind, Two-arm, Parallel Group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects

Clinical Trial Summary

A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in Healthy Male Subjects

Clinical Trial Description

This study was a randomized, double-blind, two-arm, parallel group, single-dose, phase I study designed to compare PK, PD, safety, and immunogenicity between CT-P41 and US-licensed Prolia in healthy male subjects. Subjects were randomized into a 1:1 ratio to receive a single dose (60 mg) of either CT-P41 or US-licensed Prolia. The subjects were followed up for 253 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06037395
Study type Interventional
Source Celltrion
Contact
Status Completed
Phase Phase 1
Start date October 6, 2021
Completion date October 20, 2022
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02664883 - Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer
Completed NCT05611281 - GS3-007a Oral Solution in Healthy Subjects Phase 1
Completed NCT03457480 - Text Messages in Preventing Tobacco Use in Young Adults N/A
Completed NCT05358756 - A Study of Bioavailability and Food Effect of SACT-1 and Edurant® Tablets in Healthy Adult Volunteers Phase 1
Active, not recruiting NCT04032106 - HPV Vaccine Intervention for Young Sexual Minority Men N/A
Completed NCT04062955 - Effects of Alternative Healthy Eating Index-Based Diet on Inflammatory Markers and Breast Density in Healthy Participants N/A
Recruiting NCT03897270 - Photoacoustic Imaging of the Breast in Patients With Breast Cancer and Healthy Subjects N/A
Completed NCT01846520 - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers N/A
Completed NCT02960100 - mHealth Intervention in Increasing HPV Vaccinations in College Students N/A
Completed NCT03698318 - Pharmacokinetics Assessing Bioavailability of Gingerols and Shogaols of Five Ginger Extracts N/A
Completed NCT05497635 - A Study of STSA-1002 in Healthy Subjects Phase 1
Active, not recruiting NCT03303846 - Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients N/A
Terminated NCT05559125 - A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects Phase 1
Completed NCT03584100 - Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal N/A
Recruiting NCT05117385 - The Effect of the Consumption of 4 Botanical Extracts on Immunity in Healthy Adults (B-4-Immune) N/A
Active, not recruiting NCT05660720 - Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy Subjects Phase 1
Recruiting NCT03188848 - Dose Escalating Study of BPI-3016 in Healthy Subjects Phase 1
Completed NCT01908920 - Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects N/A
Active, not recruiting NCT03491176 - Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer N/A
Completed NCT03963323 - Glucosamine and Chondroitin in Gut in Preventing People From Inflammation Phase 1