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This Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of two, single intravenous (IV) high doses of MHAA4549A as compared to placebo when administered to healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MHAA4549A higher dose | Experimental |
| |
| MHAA4549A lower dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MHAA4549A | Drug | MHAA4549A single, intravenous dose administration, lower dose level |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and nature of adverse events (AEs) | Until study discontinuation/termination, up to 120 days | |
| Changes in vital signs during and following MHAA4549A administration | From baseline to end of study, up to 120 days | |
| Changes in ECG findings during and following MHAA4549A administration | From baseline to end of study, up to 120 days | |
| Severity of AEs | Until study discontinuation/termination, up to 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (composite outcome measure): parameters derived from the nasal and serum concentration-time profile of MHAA4549A (area under the concentration-time curve [AUC], Cmax, tmax, clearance, Vss, half-life (t1/2), mean residence time) | Up to 120 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| inVentiv Health Clinique | Québec | Quebec | G1P 0A2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27381392 | Derived | Lim JJ, Deng R, Derby MA, Larouche R, Horn P, Anderson M, Maia M, Carrier S, Pelletier I, Burgess T, Kulkarni P, Newton E, Tavel JA. Two Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Studies To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza A Virus Monoclonal Antibody, MHAA4549A, in Healthy Volunteers. Antimicrob Agents Chemother. 2016 Aug 22;60(9):5437-44. doi: 10.1128/AAC.00607-16. Print 2016 Sep. |
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| ID | Term |
|---|---|
| C000631565 | gedivumab |
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| MHAA4549A | Drug | MHAA4549A single, intravenous dose administration, higher dose level |
|
| Placebo | Drug | Matching placebo to MHAA4549A administration |
|