Phase 1 Safety and Pharmacokinetics Study of Single 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: | August 2015 |
| End Date: | December 2015 |
A Double-Blind, Placebo-Controlled, Single Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers
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.
clinical trial to determine the safety and tolerability of BTA-C585 administered orally to
healthy subjects.
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
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