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

NCT03800173 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-07-23

Study results available
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Summary

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

Conditions

  • Marburg Virus Disease

Interventions

DRUG

galidesivir

galidesivir IV infusion

DRUG

placebo

placebo IV infusion

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • BioCryst Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Daniel Dickerson, MD, PhD · PRA Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2019-04-30
Completion
2019-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03800173 on ClinicalTrials.gov