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Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects

NCT04621318 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2022-11-28

No results posted yet for this study

Summary

This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16, EU sourced Prolia, and US sourced Prolia in healthy male subjects.

Conditions

  • Healthy

Interventions

DRUG

Denosumab

60 mg, single-dose

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hakim Charfi, MD · Biotrial Rennes

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
2020-10-19
Primary Completion
2022-11-09
Completion
2022-11-09
FDA Drug
Yes

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT04621318 on ClinicalTrials.gov