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The purpose of this study is to examine the safety and tolerability of HFB30132A when it is given by single intravenous infusion in Chinese healthy participants.
This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study in Chinese healthy volunteers.
The study will comprise of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFB30132A | Experimental | Participants will receive HFB30132A administered across 2 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 will receive HFB30132A dose 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent serious adverse events (TESAEs) | Number of participants experiencing TESAEs | From Day 1 to up to Day 30 after the single dose administration of HFB30132A |
| Number of participants with treatment emergent adverse events of special interest (TEAESI) | Safety and tolerability will be evaluated in terms of number of participants with TEAESI (hypersensitivity / anaphylactic reaction / local tolerability) | From Day 1 to up to Day 30 after the single dose administration of HFB30132A |
| 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 after the single dose administration of HFB30132A |
| Number of participants with changes in laboratory values, vital signs and ECG parameters | Safety and tolerability will be evaluated in terms of number of participants with changes in laboratory values, vital signs and ECG parameters | From Day 1 to up to Day 30 after the single dose administration of HFB30132A |
| Maximum observed serum concentration (Cmax) | 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-∞) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Shanghai | China |
| 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. | |
| 37332355 |
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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. |
|
| 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 |
| Systemic clearance (CL) | From Day 1 to up to Day 30 of the last enrolled subject |
| Apparent volume of distribution (Vd) | From Day 1 to up to Day 30 of the last enrolled subject |
| Li S, Wu X, Li N, Cao G, Wang J, Chen Y, Li S, He J, Wu J, Yang H, Lin K, Qiu C, Liu A, Zhou H, Adrian F, Schweizer L, Zhang W, Gu J, Zhang J. Safety, tolerability, pharmacokinetics, and immunogenicity of an anti-SARS-CoV-2 monoclonal antibody HFB30132A after single dose intravenous administration in healthy Chinese subjects: a phase 1, randomized, double-blind, placebo-controlled study. Front Pharmacol. 2023 May 23;14:1117293. doi: 10.3389/fphar.2023.1117293. eCollection 2023. |