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

NCT ID: NCT04788017

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-24
• Study Completion Date: 2021-07-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

ziresovir

The study drugs will be administered to subjects by CRU staff at approximately 8:00 a.m. (± 1 hour), following an overnight fast.

Immediately following administration of the assigned dose of the study drugs, subjects will be given water such that their water consumption is approximately 240 mL as follows:

• If administered 60 mL as the study drug dose, follow with approximately 180 mL water.
• If administered 120 mL as the study drug dose, follow with approximately 120 mL water.
• If administered 180 mL as the study drug dose, follow with approximately 60 mL water.

Group Type: ACTIVE_COMPARATOR

Ziresovir

Intervention Type: DRUG

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

placebo

The study drugs will be administered to subjects by CRU staff at approximately 8:00 a.m. (± 1 hour), following an overnight fast.

Immediately following administration of the assigned dose of the study drugs, subjects will be given water such that their water consumption is approximately 240 mL as follows:

• If administered 60 mL as the study drug dose, follow with approximately 180 mL water.
• If administered 120 mL as the study drug dose, follow with approximately 120 mL water.
• If administered 180 mL as the study drug dose, follow with approximately 60 mL water.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: OTHER

Other Intervention Names

AK0529

Eligibility Criteria

Inclusion Criteria

1. Capable of giving written informed consent and complying with study procedures;

2. Between the ages of 18 and 55 years, inclusive;

3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg;

4. Female subjects must have a negative pregnancy test result at screening;

5. Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, 12-lead ECG, and vital signs;

6. Willing and being able to adhere to study restrictions and to be confined at the Clinical Research Unit.

Exclusion Criteria

1. Clinically significant reported history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;

2. Poor venous access;

3. Taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer;

4. Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the study drug dose;

5. Major surgery or hospitalization within 6 months prior to screening that in the Investigator's opinion would put the subject or study conduct at risk, or have any scheduled surgery or hospitalization during the study period;

6. Any condition or finding that in the Investigator's opinion would put the subject or study conduct at risk if the subject were to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Ark Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jimmy Gu

Role: STUDY_DIRECTOR

Ark Biosciences

Locations

Frontage

Secaucus, New Jersey, United States

Countries

United States

Other Identifiers

AK0529-3001

Identifier Type: -

Identifier Source: org_study_id