Safety and Pharmacokinetics Study of Multiple 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 single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in healthy subjects.

Key facts

Study ID

NCT02668367

Run by

Biota Pharmaceuticals, Inc.

People needed

36

Starts

2015-11-01

Expected to finish

2016-02-01

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;
• Age 18 to 60 years, inclusive;
• Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32, inclusive;
• Female subjects must be of non-childbearing potential;
• Male subjects must agree to use a double barrier method of birth control;
• Signed informed consent form (ICF) prior to study procedures.

You may not qualify if…

• Current or recent (within 14 days of Day 0) bacterial or viral infection;
• Positive results at screening for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody;
• Clinically significant abnormalities noted on ECG;
• Safety laboratory abnormalities;
• Regular use of medications, prescription or non-prescription;
• Poor vein access or fear of venipuncture or sight of blood;
• 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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