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The purpose of this study is to test the safety and tolerability of HFB30132A when it is given by intravenously to healthy participants. Blood tests will be done to check how much HFB30132A is in the bloodstream and how long the body takes to eliminate it. Participation may include up to ten visits to the study center.
This is a Phase I, first time in human, randomized, double-blind, placebo-controlled, and dose escalation study in healthy volunteers.
The study will comprise of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFB30132A | Experimental | Participants will receive HFB30132A administered across 3 fixed-dose cohorts via intravenous infusions (to be administered sequentially) |
|
| Placebo | Placebo Comparator | Placebo will be administered to participants across three fixed-dose cohorts similar to the active treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFB30132A | Drug | Participants randomized to HFB30132A will be administered dose 1 in cohort 1. Participants in Cohort 2 and 3 will receive HFB30132A doses 2 and 3, respectively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent serious adverse events (TESAEs) | Number of participants experiencing TEAEs | From Day 1 to up to Day 30 of the last enrolled subject |
| Number of participants with treatment emergent adverse events (TEAE) of special interest | Safety and tolerability will be evaluated in terms of number of participants with TEAEs of special interest (hypersensitivity / anaphylactic reaction / local tolerability) | From Day 1 to up to Day 30 of the last enrolled subject |
| Number of participants with treatment-emergent adverse events (TEAE) | Safety and tolerability will be evaluated in terms of number of participants with TEAE | From Day 1 to up to Day 30 of the last enrolled subject |
| Maximum observed serum concentration (Cmax) | From Day 1 to up to Day 30 of the last enrolled subject | |
| Minimum observed serum concentration (Cmin) | From Day 1 to up to Day 30 of the last enrolled subject | |
| Time of maximum serum concentration (Tmax) | From Day 1 to up to Day 30 of the last enrolled subject | |
| Area under the concentration vs. time curve (AUC0-last), AUC0-∞) | From Day 1 to up to Day 30 of the last enrolled subject | |
| Terminal half-life (T1/2) | From Day 1 to up to Day 30 of the last enrolled subject |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | Safety and tolerability will be evaluated in terms of number of participants with TEAEs | From Day 1 to up to last follow-up day (Day 180) |
| Number of participants with treatment-emergent serious adverse events (TESAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leela Vrishabhendra, MD | Medpace, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace Clinical Pharmacology Unit | Cincinnati | Ohio | 45227 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39793935 | Derived | Chen Y, Li S, Hedrich W, Wu X, Li S, Qiu C, Lin K, Bian X, He J, Zhou H, Adrian F, Schweizer L, Zhang J. Population pharmacokinetics and pharmacodynamics of HFB30132A, a monoclonal antibody against SARS-CoV-2, in healthy Chinese and US subjects. Int J Antimicrob Agents. 2025 Mar;65(3):107439. doi: 10.1016/j.ijantimicag.2024.107439. Epub 2025 Jan 9. | |
| 34473343 |
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| ID | Term |
|---|---|
| C000722387 | enuzovimab |
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| Placebo | Other | Participants randomized to placebo will receive the same volume of solution as participants on active treatment. |
|
| Systemic clearance (CL) | From Day 1 to up to Day 30 of the last enrolled subject |
| Steady-state volume of distribution (Vss) | From Day 1 to up to Day 30 of the last enrolled subject |
Safety and tolerability will be evaluated in terms of number of participants with TESAEs |
| From Day 1 to up to last follow-up day (Day 180) |
| Maximum observed serum HFB30132A concentration (Cmax) in nasal and oral secretions | From Day 1 to up to last follow-up day (Day 180) |
| Minimum observed serum HFB30132A concentration (Cmin) in nasal and oral secretions | From Day 1 to up to last follow-up day (Day 180) |
| Time of maximum serum HFB30132A concentration (Tmax) in nasal and oral secretions | From Day 1 to up to last follow-up day (Day 180) |
| Area under the concentration vs. time curve (AUC0-last), AUC0-∞) in nasal and oral secretions | From Day 1 to up to last follow-up day (Day 180) |
| Terminal half-life (T1/2) of HFB30132A in nasal and oral secretions | From Day 1 to up to last follow-up day (Day 190) |
| Systemic clearance (CL) of HFB30132A in nasal and oral secretions | From Day 1 to up to last follow-up day (Day 180) |
| Steady-state volume of distribution (Vss) of HFB30132A in nasal and oral secretions | From Day 1 to up to last follow-up day (Day 180) |
| HFB30132A Anti-drug antibodies | Presence or absence of antibodies against HFB30132A over time | From Day 1 to up to last follow-up day (Day 180) |
| Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |