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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-28

Study Completion Date

2023-10-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.

NCT04535167

Viral Disease

COMPLETED PHASE1

Study to Evaluate the Efficacy of IN STI-9199 in Treating Symptomatic COVID-19 in Outpatient Adults and Adolescents

NCT05372783

COVID-19

WITHDRAWN PHASE2

Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)

NCT04575597

Coronavirus Disease (COVID-19)

COMPLETED PHASE2/PHASE3

Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)

NCT04575584

Coronavirus Disease (COVID-19)

TERMINATED PHASE2/PHASE3

This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)

NCT04593641

SARS-CoV-2 Infection

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS CoV 2 Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ASC10

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

Group Type EXPERIMENTAL

ASC10

Intervention Type DRUG

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

Placebo

Participants will be randomized to receive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will be randomized to receive placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ASC10

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

Intervention Type DRUG

Placebo

Participants will be randomized to receive placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No