Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients
Primary Purpose
SARS CoV 2 Infection
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ASC10
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for SARS CoV 2 Infection focused on measuring ASC10, RdRp
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Pinnacle Research Group
- Aga Clinical Trials
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ASC10
Placebo
Arm Description
Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days
Participants will be randomized to receive placebo
Outcomes
Primary Outcome Measures
Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses
PK parameters for ASC10, GLC01-700 (molnupiravir) and ASC10-A in plasma as AUC0-12h
Secondary Outcome Measures
Time (days) to sustained resolution of all targeted COVID-19 signs/symptoms
Full Information
NCT ID
NCT05596045
First Posted
October 25, 2022
Last Updated
October 28, 2022
Sponsor
Ascletis Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05596045
Brief Title
Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 28, 2022 (Anticipated)
Primary Completion Date
March 8, 2023 (Anticipated)
Study Completion Date
October 9, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascletis Pharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS CoV 2 Infection
Keywords
ASC10, RdRp
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ASC10
Arm Type
Experimental
Arm Description
Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to receive placebo
Intervention Type
Drug
Intervention Name(s)
ASC10
Intervention Description
Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will be randomized to receive placebo
Primary Outcome Measure Information:
Title
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
Title
PK parameters for ASC10, GLC01-700 (molnupiravir) and ASC10-A in plasma as AUC0-12h
Time Frame
From Day 1 to Day 6
Secondary Outcome Measure Information:
Title
Time (days) to sustained resolution of all targeted COVID-19 signs/symptoms
Time Frame
From Day 1 to Study Completion, up to 32 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Handan He, Doctor
Phone
+8657185389730
Email
handan.he@ascletis.com
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Aga Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Aguirre
Phone
305-819-6990
Email
RAGUIRRE@AGACLINICALTRIALS.COM
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients
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