NCT02558413

Phase 1 Safety and Pharmacokinetics Study of Single Ascending Doses of BTA-C585 in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Biota Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pharmacokinetics
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	BTA-C585 oral capsules	BTA-C585; Single ascending doses from 50 mg to 800 mg
DRUG	BTA-C585 matching placebo	Single ascending doses to match 50 to 800 mg BTA-C585 capsules

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-09-24
• Last updated: 2018-05-30

Locations

1 site across 1 country: United States