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

NCT06037395 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2023-09-14

No results posted yet for this study

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

Conditions

  • Healthy Subject

Interventions

BIOLOGICAL

CT-P41

a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)

BIOLOGICAL

US-licensed Prolia

a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
28 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2022-10-20
Completion
2022-10-20

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06037395 on ClinicalTrials.gov