Trials / Completed
CompletedNCT00192465
Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 in Healthy Adults
A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 (NUMAX TM), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Healthy Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
To provide safety, tolerability, pharmacokinetic, and immunogenicity data for MEDI-524 administered initially as a single dose to healthy adults in a dose escalation safety study before testing in the targeted pediatric population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MEDI-524 (Numax-TM) | Grp.1: 3 mg/kg IV (single dose) |
| BIOLOGICAL | MEDI-524 (Numax-TM) | Grp. 2: 15 mg/kg IV (single dose) |
| BIOLOGICAL | MEDI-524 (Numax-TM) | Grp. 3: 30 mg/kg IV (single dose) |
| BIOLOGICAL | MEDI-524 (Numax-TM) | Grp. 4: 3 mg/kg IM (single dose) |
| BIOLOGICAL | MEDI-524 (Numax-TM) | Grp.5: 3 mg/kg IM (two doses) |
Timeline
- Start date
- 2003-11-01
- Primary completion
- 2004-04-01
- Completion
- 2004-11-01
- First posted
- 2005-09-19
- Last updated
- 2009-01-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00192465. Inclusion in this directory is not an endorsement.