The trial is taking place at:
P

Pinnacle Research Group | Anniston, AL

Veeva-enabled site

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

A

Ascletis

Status and phase

Not yet enrolling
Phase 1

Conditions

SARS CoV 2 Infection

Treatments

Drug: Placebo
Drug: ASC10

Study type

Interventional

Funder types

Industry

Identifiers

NCT05596045
ASC10-102

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

32 participants in 2 patient groups, including a placebo group

ASC10
Experimental group
Description:
Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days
Treatment:
Drug: ASC10
Placebo
Placebo Comparator group
Description:
Participants will be randomized to receive placebo
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Central trial contact

Handan He, Doctor

Data sourced from clinicaltrials.gov

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