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

Ascletis

Status and phase: Not yet enrolling; Phase 1

Conditions: SARS CoV 2 Infection

Treatments: Drug: Placebo; Drug: ASC10

Study type: Interventional

Funder types: Industry

Identifiers

NCT05596045

ASC10-102

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

ASC10

Experimental group

Description:

Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days

Treatment:

Drug: ASC10

Placebo

Placebo Comparator group

Description:

Participants will be randomized to receive placebo

Treatment:

Drug: Placebo