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

Phase 1

Withdrawn

• Conditions: SARS CoV 2 Infection
• Interventions: Drug: ASC10; Drug: Placebo

• Registration Number: NCT05596045
• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-27
• Study Start: 2022-11-28
• Primary Completion: 2023-03-08
• Study Completion: 2023-10-09
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 32

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ASC10	ASC10	Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days
Placebo	Placebo	Participants will be randomized to receive placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time (days) to sustained resolution of all targeted COVID-19 signs/symptoms	From Day 1 to Study Completion, up to 32 days

Trial Locations

Locations (2)

Pinnacle Research Group; 🇺🇸 Anniston, Alabama, United States

Aga Clinical Trials; 🇺🇸 Hialeah, Florida, United States