Study to Evaluate Safety, Tolerability, Pharmacokinetics and the Food Effect on PK of ASC10 Tablets in Healthy Subjects

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of ASC10 Tablets and an Open-label, Crossover Design to Evaluate the Food Effect on PK of ASC10 in Healthy Subjects

This is a phase I, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of ASC10 tablets and an open-label, crossover design to evaluate the food effect on PK of ASC10 in healthy subjects

Study Overview

• Status: Active, not recruiting
• Conditions: SARS CoV 2 Infection
• Intervention / Treatment: Drug: ASC10; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female volunteers between the ages 18 and 45, inclusive
• Those 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.
• Body mass index (BMI) was between 19 and 26 kg/m^2. Weight ≥50 kg for males and ≥45 kg for females.

Exclusion Criteria:

• Females who are pregnant, planning to become pregnant, or breastfeeding.
• Has any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
• Has a history of cancer (other than basal cell or squamous cell cancer of the skin), rheumatologic disease or blood dyscrasias.
• Has a history of blood dizziness or difficulty in blood collection.
• Has donated blood within 30 days, plasma within 2 weeks, or platelets within 6 weeks before the first dose of study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASC10; Part 1: Participants will be randomized to receive 100 to 1600 mg ASC10 (including 6 cohorts) in an double-blind manner Part 2: Participants will be randomized to receive two single 800 mg doses (fed or fasted)	Drug: ASC10; Part 1: Participants will be randomized to receive twice daily dosing either ASC10 or Placebo for 5.5 days, in an double-blind manner Part 2: Two single oral doses of ASC10 will be administered to participants, in an open-label manner
Placebo Comparator: Placebo; Part 1: Participants will be randomized to receive placebo	Drug: Placebo; Part 1: Participants will be randomized to receive twice daily dosing either ASC10 or Placebo, in an double-blind manner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part1: Number of participants with Treatment Emergent Adverse Events (TEAEs) in multiple ascending dose (MAD)		From screening through study completion, up to 12 days
Part1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs in MAD	Vital signs evaluation includes: systolic and diastolic blood pressure (BP), temperature, respiratory rate and pulse rate.	From screening through study completion, up to 12 days
Part1: Number of Participants With Laboratory Abnormalities in MAD		From screening through study completion, up to 12 days

Collaborators and Investigators

• Sponsor: Ascletis Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Yunqing Qiu, Master, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Actual): November 11, 2022
• Study Completion (Anticipated): January 5, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Healthy; ASC10; RdRp
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ASC10-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No