A Sequential-Cohort, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers

NCT02668367 Phase 1 COMPLETED

This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in healthy subjects.

Details

Lead sponsor	Biota Pharmaceuticals, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	36
Start date	2015-11
Completion	2016-02

Conditions

• Pharmacokinetics
• Healthy Volunteers

Interventions

• BTA-C585 oral capsules
• BTA-C585 matching placebo

Primary outcomes

• Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours — 0-24 hours
• Number of adverse events — Day -1 to Day 14

Countries

United States