Trials / Completed
CompletedNCT02255760
Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults
A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of MEDI3902 in Healthy Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy adult subjects 18 to 60 years of age.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy adult subjects 18 to 60 years of age. Approximately 40 subjects will be enrolled across 4 fixed dose cohorts at 1 study site. This study will last approximately 90 days, constituting a screening period of up to 28 days, 1 day of investigational product administration, and a 60 day safety follow up period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MEDI3902 - Dose 1 | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. |
| DRUG | MEDI3902 - Dose 2 | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. |
| DRUG | MEDI3902 - Dose 3 | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. |
| DRUG | MEDI3902 - Dose 4 | Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
| OTHER | Placebo | Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours. |
Timeline
- Start date
- 2014-09-04
- Primary completion
- 2015-04-20
- Completion
- 2015-04-20
- First posted
- 2014-10-03
- Last updated
- 2018-08-13
- Results posted
- 2018-08-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02255760. Inclusion in this directory is not an endorsement.