NCT02394314

A Phase 1, Single Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers

A Phase 1, Single-ascending-dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the safety and pharmacokinetics of MEDI0382 in healthy volunteers.

Detailed description

This is a first-time-in-humans (FTIH), randomized, double-blind study designed to evaluate the safety, tolerability, and PK of MEDI0382 administered as single-ascending SC doses to healthy subjects (age 18-45). Eight subjects per cohort will be enrolled in a total of 8 cohorts. The decision whether or not to dose escalate will be based upon data review by the Dose Escalation Committee (DEC). Within each cohort, the subjects will be randomized to MEDI0382 or placebo (3:1). Following screening, the study duration for each subject will be approximately 29 days, consisting of an inpatient evaluation period, and an outpatient follow-up period.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	MEDI0382	MEDI0382 administered subcutaneously
DRUG	Placebo	Placebo administered subcutaneously

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-03-20
• Last updated: 2015-09-09

Locations

1 site across 1 country: Germany