First-in-human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of CC-90001

Summary

First-in-human study to evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of CC-90001

Conditions

• Healthy Volunteers

Interventions

DRUG

CC-90001

CC-90001 10mg will be administered as a single dose

DRUG

CC-90001

CC-90001 30mg will be administered as a single dose

DRUG

CC-90001

CC-90001 60mg will be administered as a single dose

DRUG

CC-90001

CC-90001 120mg will be administered as a single dose

DRUG

CC-90001

CC-90001 240mg will be administered as a single dose

DRUG

CC-90001

CC-90001 10mg will be administered daily for 14 days

DRUG

CC-90001

CC-90001 30mg will be administered daily for 14 days

DRUG

CC-90001

CC-90001 60mg will be administered daily for 14 days

DRUG

CC-90001

CC-90001 120mg will be administered daily for 14 days

DRUG

CC-90001

CC-90001 240mg will be administered daily for 14 days

DRUG

Placebo

Placebo will be administered once daily for up to 14 days depending on the Part of the study

DRUG

CC-90001

CC-90001 480mg will be administered as a single oral dose

DRUG

CC-90001

CC-90001 720mg will be administered as a single oral dose

DRUG

CC-90001

CC-90001 480mg will be administered daily for 14 days

Sponsors & Collaborators

• Celgene Corporation

  lead INDUSTRY

Principal Investigators

• Daniel Weiss, MD · Celgene Corporation

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2014-09-30

Completion

2014-09-30

Countries

• United States

Study Locations