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

NCT02558413 Phase 1 COMPLETED

This is a placebo-controlled, double-blind, randomized, single dose escalation Phase 1 clinical trial to determine the safety and tolerability of BTA-C585 administered orally to healthy subjects.

Details

Lead sponsor	Biota Pharmaceuticals, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	60
Start date	2015-08
Completion	2015-12

Conditions

• Pharmacokinetics
• Healthy Volunteers

Interventions

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

Primary outcomes

• Number of adverse events — Day 0 to Day 11
• Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours — 0-24 hours

Countries

United States