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

PHASE1CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

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

Trial Locations (1)

78744

PPD Development, LP, Austin

Sponsors
All Listed Sponsors
lead

Celgene Corporation

INDUSTRY