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| ID | Type | Description | Link |
|---|---|---|---|
| DMID 14-0030 | Other Identifier | NIAID/ Division of Microbiology and Infectious Diseases |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of BCX4430 administered via intramuscular (IM) injection in healthy subjects. In part 1, subjects will receive a single dose of BCX4430; in part 2 subjects will receive BCX4430 for 7 days.
Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics of single, ascending doses of BCX4430 versus placebo in healthy subjects. Up to 6 ascending dose cohorts will be enrolled in a sequential manner. Eight subjects will be treated with a single dose of study drug per dose cohort: 6 subjects per cohort will receive BCX4430, and 2 subjects per cohort will receive matching placebo.
Part 2 of the study will be initiated following review of all available data from Part 1 by an independent Safety Monitoring Committee
Part 2 of the study will evaluate the safety, tolerability, and pharmacokinetics of 7 days of daily dosing with BCX4430 versus placebo in healthy subjects. Up to 4 ascending dose cohorts will be treated in a sequential manner. Ten subjects will be treated with study drug per dose cohort (8 subjects will receive BCX4430 and 2 subjects will receive placebo per cohort). The planned doses and dosing regimens for each of the Part 2 cohorts will be determined based upon data collected during Part 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCX4430 | Experimental | BCX4430 administered as an IM injection |
|
| Placebo | Placebo Comparator | Matched placebo administered as an IM injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCX4430 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, measured by the frequency and severity of adverse events, laboratory abnormalities and other safety parameters following single (Part 1) and multiple (Part 2) doses of BCX4430 | Evaluation of the incidence and severity of adverse events, laboratory abnormalities, ECG findings, vital sign changes, injection site and physical examination findings | Part 1: 7 days. Part 2: 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma exposure of BCX4430, determined by the concentration time profile and PK parameters following single (Part 1) and multiple (Part 2) doses of BCX4430 | Part 1: 7 days. Part 2: 14 days | |
| The urinary elimination of BCX4430, determined by the concentration of drug following single (Part 1) and multiple (Part 2) doses of BCX4430 |
| Measure | Description | Time Frame |
|---|---|---|
| The levels of BCX6870, the triphosphate metabolite of BCX4430, in peripheral blood mononuclear cells following single (Part 1) and multiple (Part 2) doses of BCX4430 | Part 1: 7 days. Part 2: 14 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jo Collier, MBChB | Quotient Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Ruddington | NG11 6JS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35182042 | Derived | Mathis A, Collins D, Dobo S, Walling DM, Sheridan WP, Taylor R. Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2022 Apr;11(4):467-474. doi: 10.1002/cpdd.1037. Epub 2022 Feb 19. |
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| ID | Term |
|---|---|
| D018702 | Filoviridae Infections |
| D019142 | Hemorrhagic Fever, Ebola |
| ID | Term |
|---|---|
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C517546 | galidesivir |
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|
| Part 1: 7 days. Part 2: 14 days |
| D006482 |
| Hemorrhagic Fevers, Viral |