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

NCT05596045 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: ASC10-102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

SARS CoV 2 Infection

Keywords

ASC10; RdRp

Outcome Measures

Primary Outcomes (2)

• Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses

  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

  From Day 1 to Day 6

Secondary Outcomes (1)

• Time (days) to sustained resolution of all targeted COVID-19 signs/symptoms

  From Day 1 to Study Completion, up to 32 days

Study Arms (2)

ASC10

EXPERIMENTAL

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

Drug: ASC10

Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive placebo

Drug: Placebo

Interventions

ASC10 DRUG

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

ASC10

Placebo DRUG

Participants will be randomized to receive placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead

Study Sites (2)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Aga Clinical Trials

Hialeah, Florida, 33012, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 27, 2022
• Study Start: November 28, 2022
• Primary Completion: March 8, 2023
• Study Completion: October 9, 2023
• Last Updated: November 1, 2024

Record last verified: 2022-10

Locations

US (2)