A Phase 1 Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BCX4430 Administered Via Intramuscular Injection (IM) in Healthy Subjects
Sponsor study identifier
Secondary identifiers
OTHER · NIAID/ Division of Microbiology and Infectious Diseases
interventional
94
1 country
1
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Actual (reported)Study Completion
April 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
December 11, 2014
Actual (reported)December 18, 2014
Actual (reported)March 2016
Actual (reported)April 2016
Actual (reported)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
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
Part 1: 7 days. Part 2: 14 days
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
BCX4430 administered as an IM injection
Matched placebo administered as an IM injection
Quotient Clinical
Ruddington, NG11 6JS, United Kingdom
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.
Jo Collier, MBChB
Quotient Clinical
94 participants (actual enrollment reported by the registry).
First Submitted
December 11, 2014
First Posted
December 18, 2014
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine (rVSVΔG-ZEBOV-GP)
Contact the study team to confirm eligibility.
Primary Completion
March 2016
Actual (reported)Study Completion
April 2016
Actual (reported)Last Updated
July 7, 2016
Record last verified: 2016-07
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Source: ClinicalTrials.gov.
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