NCT05718518

Study to Evaluate Safety, Tolerability, PK and the Food Effect on PK of ASC11/RTV Tablets in Healthy Subjects

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and PK of ASC11/RTV Tablets and Study to Evaluate the Effects of Food on the PK of ASC11/RTV Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Ascletis Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety, tolerability, and pharmacokinetics of ASC11 plus ritonavir tablets in healthy subjects and an open-label, cross-over study evaluating the effect of food on the pharmacokinetics of ASC11 plus ritonavir tablets

Conditions

• Healthy
• COVID-19

Interventions

Type	Name	Description
DRUG	ASC11 tablets	Part 1: Subjects will receive ASC11 tablets on single ascending doses with proposed dose levels of ASC11 tablets: 100mg (cohort 1), 200 mg (cohort 2), 400mg (cohort 3) and 800 mg (cohort 4). Part 2: Subjects will receive ASC11tablets 100 to 300 mg (including 3 cohorts) and ASC11 tablets 300 mg(cohort 4) twice daily (BID) for 5 consecutive days and receive a single dose in the early morning of Day 6. Part 3: Subjects will be randomized to receive ASC11 tablets two single 200 mg or 300 mg doses (fed or fasted)
DRUG	Placebo	Part 1 and 2: Subjects will be randomized to receive placebo.
DRUG	RTV tablets	Part 1: Subjects will receive RTV tablets on 100 mg (cohort 1-4). Part 2: Subjects will receive RTV tablets 100 mg (including 3 cohorts) twice daily (BID) for 5 consecutive days and receive a single dose in the early morning of Day 6. Part 3: Subjects will be randomized to receive two single 100 mg doses (fed or fasted)

Timeline

• Start date: 2023-01-13
• Primary completion: 2023-04-14
• Completion: 2023-04-14
• First posted: 2023-02-08
• Last updated: 2024-11-13

Locations

1 site across 1 country: China