A Phase 1, Randomized, Blinded, Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Overweight/Obese Subjects of Japanese or Chinese Descent

Registration

Registration

NCT03385369

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

TRIPLE

Status

COMPLETED

Enrollment

32

Start

2018-01-05

Primary completion

2018-04-12

Lead sponsor

MedImmune LLC

Conditions

Safety; Healthy Subjects

Interventions

DRUG:MEDI0382; DRUG:Placebo

Results posted

FALSE

Individual participant data sharing

UNDECIDED

Registered primary outcomes

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [Day 1 through Day 29]
• Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESIs) [Day 1 through Day 29]
• Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs [Day 1 through Day 29]
• Number of Participants With Vital Signs Abnormalities Reported as TEAEs [Day 1 through Day 29]
• Number of Participants With Abnormal Laboratory parameters Reported as TEAEs [Day 1 through Day 29]