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

Study Overview
=================
Brief 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.

Official Title
-----------------
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 Patients

Conditions
-----------------
SARS CoV 2 Infection

Intervention / Treatment
-----------------
* Drug: ASC10
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects aged ≥18 years at screening; 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; If male, agree to use adequate contraception throughout the study and for at least 3 months after the last dose of study drug; Has a documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤5 days prior to randomization. Exclusion Criteria: Females who are pregnant, planning to become pregnant, or breastfeeding; Has at least one characteristic or underlying medical condition associated with an increased risk of developing severe or critical illness from COVID-19; Has hypersensitivity or other contraindication to any of the components of the study interventions; 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASC10<br>Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days | Drug: ASC10<br>* Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days<br>|
| Placebo Comparator: Placebo<br>Participants will be randomized to receive placebo | Drug: Placebo<br>* Participants will be randomized to receive placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses |  | From Day 0 to Study Completion, up to 32 days | 
| PK parameters for ASC10, GLC01-700 (molnupiravir) and ASC10-A in plasma as AUC0-12h |  | From Day 1 to Day 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (days) to sustained resolution of all targeted COVID-19 signs/symptoms |  | From Day 1 to Study Completion, up to 32 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASC10, RdRp