Study of PBI-0451 in Healthy Subjects.

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1, placebo-controlled, blinded, randomized, dose escalation study of PBI-0451 in healthy subjects. PBI-0451 is a new chemical entity and inhibitor of the main protease of coronaviruses, including the SARS-CoV-2 that causes COVID-19 disease. The study is designed to evaluate the safety, tolerability and pharmacokinetics of PBI-0451 after single and multiple ascending doses and also to explore drug-drug interaction potential of PBI-0451.

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

Details

• Lead Sponsor: Pardes Biosciences, Inc.
• Treatments: Midazolam; Ritonavir

Criteria

Inclusion Criteria:

1. Non-smoking, healthy male or female subjects aged 18-59 years.

2. Body Mass Index (BMI) of ≥ 19.0 and ≤ 30.0 kg/m2.

3. 12-Lead electrocardiogram (ECG) evaluation without clinically significant abnormalities.

4. Normal renal function, including having a creatinine clearance (CLcr) ≥90mL/min

5. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

6. Screening laboratory assessments must be without clinically significant abnormalities as assessed by the investigator.

Exclusion Criteria:

1. Pregnant and lactating females

2. Have received any investigational drug (or vaccine) within the last 30 days prior to study dosing.

3. Have a positive test result for HIV or HBsAg.

4. Have poor venous access that limits phlebotomy

5. Have taken any prescription medications or over-the-counter medications, including herbal products and dietary supplements within 28 days prior to start of study.

6. Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to Screening or is expected to receive these agents during the study.

7. Have a history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.

8. Have a history of significant drug sensitivity, cardiac disease, syncope, palpitations, or unexplained dizziness, implanted defibrillator or pacemaker, liver disease, severe peptic ulcer disease, gastroesophageal reflux disease and a medical or surgical treatment that permanently altered gastric absorption.

9. Have received inactivated vaccinations within 4 weeks prior to randomization or receive live vaccinations within 4 weeks of Screening.

10. Received the COVID-19 vaccine either within 7 days or have not completed the series of required 2 doses.

11. Have a history of excessive alcohol use or other illicit drug use within 6 months of screening.