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This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of MHAB5553A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental |
| |
| Cohort B | Experimental |
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| Cohort C | Experimental |
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| Cohort D | Experimental |
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| Cohort E | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MHAB5553A | Drug | Single intravenous administration, at various doses, depending on the cohort |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events, graded by severity | Until study discontinuation/termination, up to 120 days | |
| Changes in vital signs during and following MHAB5553A administration | Throughout the study, up to 120 days | |
| Changes in physical examination finding during and following MHAB5553A administration | Throughout the study, up to 120 days | |
| Changes in clinical laboratory results during and following MHAB5553A administration | Throughout the study, up to 120 days | |
| Changes in electrocardiogram (ECG) findings during and following MHAB5553A | Throughout the study, up to 120 days | |
| Incidence of serum anti-MHAB5553A antibodies | Until study discontinuation/termination, up to 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration (Cmax) of MHAB5553A | Up to 120 days | |
| Time to Cmax (tmax) of MHAB5553A | Up to 120 days | |
| Area under the concentration-time curve up to last measurable time point (AUC0-last) of MHAB5553A |
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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 | G1P 0A2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28559255 | Derived | Lim JJ, Derby MA, Zhang Y, Deng R, Larouche R, Anderson M, Maia M, Carrier S, Pelletier I, Girard J, Kulkarni P, Newton E, Tavel JA. A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza B Virus Monoclonal Antibody, MHAB5553A, in Healthy Volunteers. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00279-17. doi: 10.1128/AAC.00279-17. Print 2017 Aug. |
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| ID | Term |
|---|---|
| C000626824 | lesofavumab |
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| Matching placebo | Drug | Single intravenous dose |
|
| Up to 120 days |
| Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of MHAB5553A | Up to 120 days |
| Clearance (CL) of MHAB5553A | Up to 120 days |
| Volume of distribution at steady-state (Vss) of MHAB5553A | Up to 120 days |
| Terminal elimination half-life (t1/2) of MHAB5553A | Up to 120 days |
| Mean Residence Time (MRT) of MHAB5553A | Up to 120 days |