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Study to Evaluate the Pharmacokinetic Comparability of CC-93538 From Two Different Drug Concentrations in Healthy Adult Subjects

NCT04373187 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-09-28

No results posted yet for this study

Summary

This is an open-label, randomized, parallel design study to evaluate the PK comparability, safety, tolerability and immunogenicity of a single SC dose of 360 mg CC 93538 using two different drug concentrations, 180 mg/mL and 150 mg/mL, in healthy adult subjects.

A total of approximately 52 subjects will be enrolled and randomized 1:1 to receive a single 360 mg SC dose of CC-93538 using either 180 mg/mL (1 injection of 2 mL) or 150 mg/mL (2 injections of 1.2 mL each) drug concentrations.

Conditions

  • Healthy Volunteers

Interventions

DRUG

CC-93538

one injection of 2mL

DRUG

CC-93538

two injections of 1.2mL

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-06-22
Primary Completion
2021-05-26
Completion
2021-05-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04373187 on ClinicalTrials.gov