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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001983-52 | EudraCT Number |
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This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of MHAA4549A in healthy volunteers in an influenza challenge model. Subjects will be intranasally oculated with the challenge virus and will be randomly assigned to receive a intravenous dose of either MHAA4549A or placebo. In the stage 5 cohort, subjects will be randomly assigned to receive doses of MHAA4549A or placebo or Tamiflu (oseltamivir) orally twice daily for 5 days. All subjects in all cohorts may take Tamiflu twice daily from Day 7 to Day 11.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MHAA4549A | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Tamiflu | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MHAA549A | Drug | IV dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Viral area under the concentration-time curve (AUC) of nasopharyngeal viral load by quantitative Polymerase Chain Reaction (qPCR) | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | 120 days | |
| Safety: Change in lung function | from pre-challenge to Day 29 | |
| Safety: Incidence of anti-therapeutic antibodies (ATAs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retroscreen Ltd | London | NW1 0NH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28807912 | Derived | McBride JM, Lim JJ, Burgess T, Deng R, Derby MA, Maia M, Horn P, Siddiqui O, Sheinson D, Chen-Harris H, Newton EM, Fillos D, Nazzal D, Rosenberger CM, Ohlson MB, Lambkin-Williams R, Fathi H, Harris JM, Tavel JA. Phase 2 Randomized Trial of the Safety and Efficacy of MHAA4549A, a Broadly Neutralizing Monoclonal Antibody, in a Human Influenza A Virus Challenge Model. Antimicrob Agents Chemother. 2017 Oct 24;61(11):e01154-17. doi: 10.1128/AAC.01154-17. Print 2017 Nov. | |
| 28639229 |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Drug |
IV dose |
|
| oseltamivir [Tamiflu] | Drug | Orally b.i.d, 5 days |
|
| 120 days |
| Pharmacokinetics: Area under the concentration-time curve | 8 days |
| AUC of nasopharyngeal viral load, as measured by cell culture | 8 days |
| Peak viral load (qPCR and cell culture) | 8 days |
| Duration of viral shedding | 8 days |
| Duration of Grade 2 or worse symptoms (from first occurrence of any Grade >2 symptom to last occurrence of any Grade >2 symptom) | 8 days |
| Peak/AUC of composite symptoms | 8 days |
| Derived |
| Deng R, Lee AP, Maia M, Lim JJ, Burgess T, Horn P, Derby MA, Newton E, Tavel JA, Hanley WD. Pharmacokinetics of MHAA4549A, an Anti-Influenza A Monoclonal Antibody, in Healthy Subjects Challenged with Influenza A Virus in a Phase IIa Randomized Trial. Clin Pharmacokinet. 2018 Mar;57(3):367-377. doi: 10.1007/s40262-017-0564-y. |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |