Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients
Withdrawn before enrolling · Phase 1 · Has a placebo group
Conditions studied: SARS CoV 2 Infection
In brief
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.
Key facts
- Study ID
- NCT05596045
- Run by
- Ascletis Pharmaceuticals Co., Ltd.
- People needed
- 0
- Starts
- 2022-11-28
- Expected to finish
- 2023-10-09
- Last updated by the study team
- 2024-11-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pinnacle Research Group — Anniston, Alabama, United States
- Aga Clinical Trials — Hialeah, Florida, United States
Full record on ClinicalTrials.gov
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