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A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BCX4430

NCT02319772 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2016-07-07

No results posted yet for this study

Summary

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.

Conditions

  • Filovirus Infections
  • Ebola Virus Infection

Interventions

DRUG

BCX4430

DRUG

Placebo

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • BioCryst Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Jo Collier, MBChB · Quotient Clinical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-03-31
Completion
2016-04-30

Countries

  • United Kingdom

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 NCT02319772 on ClinicalTrials.gov