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

NCT05523141 | Completed Phase 1

• 1 other identifier: ASC10-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

SARS CoV 2 Infection

Keywords

ASC10; RdRp; Healthy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

ASC10

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Part 1: Participants will be randomized to receive placebo

Drug: Placebo

Interventions

ASC10 DRUG

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

ASC10

Placebo DRUG

Part 1: Participants will be randomized to receive twice daily dosing either ASC10 or Placebo, in an double-blind manner

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

• Liu J, Zhao Q, Zhai Y, Wu X, Kai J, Ruan J, Wu M, Wu M, Zhou Z, Yan Y, Wu JJ, Qiu Y. Safety, tolerability and pharmacokinetics of ASC10, a novel oral double prodrug of a broad-spectrum antiviral agent, beta-d-N4-hydroxycytidine: results from a randomized, double-blind, placebo-controlled phase 1 study in Chinese healthy subjects. Expert Opin Investig Drugs. 2024 Aug;33(8):867-876. doi: 10.1080/13543784.2024.2377318. Epub 2024 Jul 12.

  PMID: 38988285 DERIVED

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 Officials

• Yunqing Qiu, Master

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: August 31, 2022
• Study Start: October 7, 2022
• Primary Completion: November 18, 2022
• Study Completion: December 5, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

CN (1)