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Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects

NCT04514796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2021-05-26

No results posted yet for this study

Summary

This study is to evaluate to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of SB5 in healthy male subjects.

Conditions

  • Healthy

Interventions

DRUG

Adalimumab

SB5 (adalimumab), 40 mg, single-dose

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Thomas Köernicke, MD · Parexel International GmbH, Early Phase Clinical Unit Berlin

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2021-05-15
Completion
2021-05-15

Countries

  • Germany

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 NCT04514796 on ClinicalTrials.gov