NCT02388347

A Study to Assess the Safety of MEDI7836 in Healthy Adults.

A Phase 1a, Randomised, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI7836 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To assess the safety of a single ascending dose of MEDI7836 in healthy adult male subjects and healthy adult female subjects of non-childbearing potential.

Detailed description

This is a Phase 1a, randomised, blinded (the investigator and subject will be blinded to treatment assignment and sponsor will be unblinded to treatment assignment), placebo-controlled study to evaluate the safety of single-ascending SC doses of MEDI7836 in healthy adult males subjects and healthy adult female subjects of non-childbearing potential. The study will be conducted at a single site in the United Kingdom (UK). Four dosing cohorts of MEDI7836 or placebo are planned for this study for a total of 32 subjects (24 subjects receiving MEDI7836, 8 subjects receiving placebo).

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	Placebo SC	Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1.
BIOLOGICAL	MEDI7836 Dose 1	Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1.
BIOLOGICAL	MEDI7836 Dose 2	Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1.
BIOLOGICAL	MEDI7836 Dose 3	Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1.
BIOLOGICAL	MEDI7836 Dose 4	Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-01-01
• Completion: 2016-04-01
• First posted: 2015-03-17
• Last updated: 2017-05-16
• Results posted: 2017-04-12

Locations

1 site across 1 country: United Kingdom