A Phase I study of BCX4430 in healthy subjects (QCL117377)

• Research type

  Research Study

• Full title

  A PHASE 1, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF BCX4430 ADMINISTERED VIA INTRAMUSCULAR (IM) INJECTION IN HEALTHY SUBJECTS

• IRAS ID

  166458

• Contact name

  Sylvia Dobo

• Sponsor organisation

  BioCryst Pharmaceuticals

• Eudract number

  2014-004217-93

• Clinicaltrials.gov Identifier

  DMID 14-0030, DMID Protocol Number

• Duration of Study in the UK

  0 years, 7 months, 22 days

• Research summary

  The Sponsor is developing the study drug, BCX4430, for the potential treatment of a range of viruses including Ebola (EBOV) and Marburg (MARV) viruses.

  The study will try to identify the levels of study drug in plasma, identify a safe dose range, and investigate the potential levels at which the drug is effective to assist in the design of further trials.

  The study will consist of 2 parts involving up to 88 healthy male and female subjects.
  In Part 1, up to 6 cohorts of 8 subjects (BCX4430 n=6; Placebo n=2) each will be will receive a dose of BCX4430. The doses will range between 0.3 mg/ kg to 10.0 mg/kg maximum.

  In Part 2 up to 4 cohorts of 10 subjects (BCX4430 n=8; Placebo n=2) each will receive a dose that will be confirmed following formal review of Part 1 safety and PK data.
  

• REC name

  HSC REC B

• REC reference

  14/NI/1128

• Date of REC Opinion

  19 Nov 2014

• REC opinion

  Favourable Opinion