NCT04788017

A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Group, Single Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ziresovir following a single ascending oral dose administration in healthy adult subjects under fasted conditions.

Detailed description

Up to 3 dose cohorts are planned. The ziresovir dose level of each cohort is determined based on the collective clinical and nonclinical data of ziresovir. The proposed dose levels of Cohorts 1, 2 and 3 are 300 mg and up to 600 mg and up to 900 mg, respectively. A total of up to 24 subjects will be randomized with 18 subjects to receive active drug and 6 subjects to receive placebo in a double-blind fashion. Eight subjects will be randomized in each dose cohort, with 6 subjects to receive active drug and 2 subjects o receive placebo.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Ziresovir	Planned treatments are: * Cohort 1: 300 mg of ziresovir * Cohort 2: up to 600 mg of ziresovir * Cohort 3: up to 900 mg of ziresovir
OTHER	Placebo	Planned treatments are: * Cohort 1: 300 mg of placebo * Cohort 2: up to 600 mg of placebo * Cohort 3: up to 900 mg of placebo

Timeline

• Start date: 2021-03-24
• Primary completion: 2021-06-14
• Completion: 2021-07-22
• First posted: 2021-03-09
• Last updated: 2022-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study