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

Ascletis Pharmaceuticals Co., Ltd.2 sites in 1 country32 target enrollmentNovember 28, 2022

ConditionsSARS CoV 2 Infection

InterventionsASC10 Placebo

DrugsPlacebo ASC10

Overview

Phase: Phase 1
Intervention: ASC10
Conditions: SARS CoV 2 Infection
Sponsor: Ascletis Pharmaceuticals Co., Ltd.
Enrollment: 32
Locations: 2
Primary Endpoint: Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses
Status: Withdrawn
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

November 28, 2022

End Date

October 9, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Ascletis Pharmaceuticals Co., Ltd.

Responsible Party

Sponsor

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.