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

NCT05523141 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-12-16

No results posted yet for this study

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

Interventions

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Ascletis Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yunqing Qiu, Master · Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-07
Primary Completion
2022-11-18
Completion
2022-12-05

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05523141 on ClinicalTrials.gov