NCT03800173

A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430

A Phase 1 Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Galidesivir (BCX4430) Administered as Single Doses Via Intravenous Infusion in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: BioCryst Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion

Detailed description

This single ascending dose study will evaluate the safety, tolerability, and PK of single doses of galidesivir vs. placebo administered as IV infusions in healthy subjects enrolled in up to four dose cohorts of 8 subjects each. A single dose of study drug will be administered per cohort: 6 subjects will receive galidesivir IV, and 2 subjects will receive matching placebo.

Conditions

• Marburg Virus Disease

Interventions

Type	Name	Description
DRUG	galidesivir	galidesivir IV infusion
DRUG	placebo	placebo IV infusion

Timeline

• Start date: 2018-12-10
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2019-01-11
• Last updated: 2021-07-23
• Results posted: 2021-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study