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

Phase 1

Completed

• Conditions: Healthy Volunteers; Pharmacokinetics
• Interventions: Drug: BTA-C585 oral capsules; Drug: BTA-C585 matching placebo

• Registration Number: NCT02558413
• Lead Sponsor: Biota Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-24
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Healthy men and women aged 18-60 years;
• Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32;
• Female subjects must be of non-childbearing potential;
• Male subjects must agree to use a double barrier method of birth control;
• Able to provide informed consent

Exclusion Criteria

• Current or recent (within 14 days of Day 0) bacterial or viral infection;
• Positive results for hepatitis B, hepatitis C, or HIV;
• Clinically significant abnormalities noted on ECG;
• Safety laboratory abnormalities;
• Regular use of medications, prescription or non-prescription;
• Poor vein access or fear of venipuncture;
• Major surgery, significant recent injury or trauma within 30 days;
• Received an investigational drug or vaccine within 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BTA-C585 oral capsules	BTA-C585 oral capsules	25 or 100 mg oral capsules; Single ascending doses (SAD) from 50 mg to 800 mg
BTA-C585 matching placebo	BTA-C585 matching placebo	BTA-C585 Matching placebo capsules; single doses

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Biota Investigational Site; 🇺🇸 San Antonio, Texas, United States