Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients

• Status: Not yet recruiting
• Trial end date: 2023-10-09
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase Ib, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, efficacy and pharmacokinetics of ASC10 tablets in mild or moderate COVID-19 subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.

Criteria

Inclusion Criteria:

1. Male or female subjects aged ≥18 years at screening;

2. Those females who do not have plans for pregnancy within six months and are willing to take effective contraceptive measures from the first dose of the study drug to 3 months after the last dose;

3. If male, agree to use adequate contraception throughout the study and for at least 3 months after the last dose of study drug;

4. Has a documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤5 days prior to randomization.

Exclusion Criteria:

1. Females who are pregnant, planning to become pregnant, or breastfeeding;

2. Has at least one characteristic or underlying medical condition associated with an increased risk of developing severe or critical illness from COVID-19;

3. Has hypersensitivity or other contraindication to any of the components of the study interventions;

4. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.