NCT03001297

Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884

A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of MEDI5884 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in healthy volunteers

Detailed description

This is a first time in human, phase 1, randomized, blinded, placebo-controlled study to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending subcutaneous doses of MEDI5884 in healthy volunteers (age 18-55). The study consists of 4 cohorts of increasing doses (8 subjects each) and an optional Japanese American cohort (24 subjects) for a total of 56 healthy subjects. The decision whether or not to dose escalate will be based upon data review by the Dose Escalation Committee. Subjects will be randomized 3:1 to MEDI5884 or placebo. Following screening, the study consists of a 3 day inpatient stay and follow up visits. The number of follow up visits depend on the cohort assigned.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	Participants will receive single dose of placebo matched MEDI5884 injection SC on Day 1
BIOLOGICAL	MEDI5884 Dose 1	Participants will receive single dose MEDI5884 Dose 1 injection SC on Day 1.
BIOLOGICAL	MEDI5884 Dose 2	Participants will receive single dose MEDI5884 Dose 2 injection SC on Day 1
BIOLOGICAL	MEDI5884 Dose 3	Participants will receive single dose MEDI5884 Dose 3 injection SC on Day 1
BIOLOGICAL	MEDI5884 Dose 4	Participants will receive single dose MEDI5884 Dose 4 injection SC on Day 1

Timeline

• Start date: 2017-01-17
• Primary completion: 2018-08-10
• Completion: 2018-08-10
• First posted: 2016-12-23
• Last updated: 2018-08-22

Locations

1 site across 1 country: United States