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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 60
Updated:6/1/2018
Start Date:November 2015
End Date:February 2016

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

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


Inclusion Criteria:

1. Healthy men and women;

2. Age 18 to 60 years, inclusive;

3. Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32, inclusive;

4. Female subjects must be of non-childbearing potential;

5. Male subjects must agree to use a double barrier method of birth control;

6. Signed informed consent form (ICF) prior to study procedures.

Exclusion Criteria:

1. Current or recent (within 14 days of Day 0) bacterial or viral infection;

2. Positive results at screening for hepatitis B surface antigen, hepatitis C antibody,
or HIV antibody;

3. Clinically significant abnormalities noted on ECG;

4. Safety laboratory abnormalities;

5. Regular use of medications, prescription or non-prescription;

6. Poor vein access or fear of venipuncture or sight of blood;

7. Major surgery, significant recent injury or trauma within 30 days;

8. Received an investigational drug or vaccine within 30 days.
We found this trial at
1
site
San Antonio, Texas 78209
?
mi
from
San Antonio, TX
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