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

Completed · Phase 1 · Has a placebo group

Conditions studied: Pharmacokinetics, Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02558413

Run by

Biota Pharmaceuticals, Inc.

People needed

60

Starts

2015-08-01

Expected to finish

2015-12-01

Last updated by the study team

2018-05-30

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Biota Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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