FTIH Study of ECC0509 in Healthy Volunteers

• Status: Recruiting
• Trial end date: 2022-02-20
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Dose, First-Time-In-Human Study to Assess The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ECC0509 in Healthy Volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eccanga Pty Ltd
• Collaborator: Syneos Health

Criteria

Key Inclusion Criteria:

1. Healthy male or non-childbearing potential female

2. Age ≥18 and ≤65 years old

3. BMI ≥18.0 and ≤32.0 kg/m2

4. Male participants agree to use contraception

5. No clinically significant abnormal findings in physical examination, 12-lead electrocardiogram (ECG), laboratory tests, or medical history

6. Able to understand and sign informed consent

Key Exclusion Criteria:

1. Significant allergic reactions to any drug.

2. History of significant drug abuse or alcohol abuse within 1 year prior to screening

3. Concomitant participation in any investigational study of any nature

4. Use of any concomitant medication except for the occasional use of acetaminophen (up to 2 g daily)

5. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.

6. Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol breath test, or medical history which, in the opinion of the Investigator, would prevent the subject from participating in the study.