A Study of Safety, Tolerability, PK & PD SAD/MAD of BCX7353(QCL117537)
Research type
Research Study
Full title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of BCX7353 in Healthy Subjects
IRAS ID
177437
Contact name
Amanda Mathis
Contact email
Sponsor organisation
BioCryst Pharmaceuticals, Inc.
Eudract number
2015-000909-39
Duration of Study in the UK
0 years, 4 months, 21 days
Research summary
The Sponsor is developing the study drug, BCX7353, for the potential treatment of hereditary angioedema (HAE). This disorder causes episodes of swelling of the skin, throat, intestines, genitals and extremities, which can be painful, disfiguring and potentially life threatening.
This study will be the first time this study drug has been given to humans. The study will evaluate how safe and well tolerated the drug is in healthy volunteers, and identify how the body absorbs, distributes and gets rid of the drug.
The study will consist of two parts involving up to 96 healthy male and female subjects in total. In Part 1, there will be 6 dose groups, each including 8 subjects. Each subject will receive a single dose of BCX7353 or placebo orally as per the study protocol. Subjects in Group 4 will receive two doses of BCX7353 separated by 7 days (one after fasting and one after a high fat meal). In Part 2 of the study there will be 4 dose groups, each including 12 subjects. Each subject will recieve a course (7 or 14 days) of the study drug or placebo at a dose level which will be selected based on the ongoing data from the study.
REC name
Wales REC 1
REC reference
15/WA/0080
Date of REC Opinion
27 Apr 2015
REC opinion
Further Information Favourable Opinion