NCT02668367

Safety and Pharmacokinetics Study of Multiple Ascending Doses of BTA-C585 in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Biota Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Pharmacokinetics
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	BTA-C585 oral capsules	BTA-C585; Multiple ascending doses from 100 mg to 600 mg
DRUG	BTA-C585 matching placebo	Multiple ascending doses to match 100 mg to 600 mg BTA-C585 capsules

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2016-01-29
• Last updated: 2018-05-30

Locations

1 site across 1 country: United States