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

October 30, 2024 updated by: Ascletis Pharmaceuticals Co., Ltd.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group
    • Florida
      • Hialeah, Florida, United States, 33012
        • AGA Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses
Time Frame: From Day 0 to Study Completion, up to 32 days
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
Time Frame: From Day 1 to Day 6
From Day 1 to Day 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascletis Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 28, 2022

Primary Completion (Estimated)

March 8, 2023

Study Completion (Estimated)

October 9, 2023

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC10-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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