A Study of AK3280 in Chinese Healthy Volunteers

NCT ID: NCT04926116

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-09
• Study Completion Date: 2021-09-28

Brief Summary

This study is a randomized, double-blind, placebo-controlled, single-center, phase I study to evaluate the safety, tolerability, and pharmacokinetics of AK3280 in healthy Chinese subjects.

Detailed Description

This phase I study is a randomized, double-blind, placebo-controlled, single-center clinical study in healthy subjects. The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of AK3280. Approximately, 36 healthy Chinese subjects will be recruited and randomized to orally receive AK3280 or matching placebo. The total duration of the study will be approximately 25 days for each subject.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AK3280 Cohort 1

Eligible subjects will be administered a single oral dose of 200 mg AK3280 under fasted conditions on Day 1. A multiple dosing period follows with daily 200 mg AK3280 b.i.d. administered with a concurrent low-fat meal intake from Day 4 to Day 16 and a 200 mg AK3280 q.d. dosing on Day 17.

Group Type: EXPERIMENTAL

AK3280

Intervention Type: DRUG

Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral

AK3280 Cohort 2

The dose level of AK3280 for Cohort 2 will be determined by the SRC (Safety Review Committee) based on the safety and PK data gleaned in Cohort 1. Subjects will receive AK3280 following the same dosing schedule as that in Cohort 1, i. e., a single oral dose of AK3280 under fasted conditions on Day 1, multiple AK3280 b.i.d. administration with a concurrent low-fat meal intake from Day 4 to Day 16, and an AK3280 q.d. dose on Day 17.

Group Type: EXPERIMENTAL

AK3280

Intervention Type: DRUG

Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral

AK3280 Optional Cohort

This is an optional dose cohort that the SRC will determine depending on the results of Cohorts 1 and 2, including the proposed dose level. Potential subjects in this cohort will also follow the same dosing scheme as those for Cohorts 1 and 2.

Group Type: EXPERIMENTAL

AK3280

Intervention Type: DRUG

Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral

Control Arm

There are placebo controls in each dose cohort to assess the safety profile of the study medication. Subjects will be randomized to receive a placebo simultaneously as those subjects randomized to AK3280.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral

Interventions

AK3280

Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral

Intervention Type: DRUG

Placebo

Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants who are willing to sign and date informed consent forms.
• Male or female participants between 18 and 45 years of age, inclusive.
• Have a bodyweight ≥50.0 kg (Male) or ≥45.0 kg (Female), and a body mass index (BMI) between 19.0 and 28.0 kg/m^2, inclusive.
• Participants are in good health without any significant clinical abnormalities on the basis of medical history related to heart, liver, kidneys, gastrointestinal tracts, or mental, central nervous, and metabolic disorders; physical examination (including vital signs); baseline laboratory test and 12-lead electrocardiogram (ECG) results.
• Participants (including male participants) who have no pregnancy plan and are willing to use an effective method of contraception during the screening period and for three months thereafter without sperm or egg donation plans.
• Participants who are capable to communicate with investigators and comply with the study requirements.

Exclusion Criteria

• Allergic to any of the study drug ingredients or ineligible determined by the investigator due to a history of food or drug allergies.
• Having an abnormal medical history in terms of clinically significant digestive, urological, neurological, hematological, endocrine, oncological, pulmonary, immunological, cardiovascular, or psychiatric diseases or having histories of use any prescription, over-the-counter, herbs, vitamins, or vaccines within four weeks prior to study drug administration.
• Intolerant to venipuncture or having difficulty in venous blood collection.
• Having a personal history of drug and alcohol abuse, use of nicotine-containing products, receiving caffeine-containing drinks, taking grapefruit or food made of it, and medications, food, or beverages such as xanthines that could affect the ADME of study medication.
• Having clinically significant abnormalities in vital sign measures and lab test results.
• Female subjects are lactating at screening.
• Previous participation in any clinical trial within 3 months prior to screening.
• Inability to meet the study requirements in the opinion of the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 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

info@arkbiosciences.com

Locations

China-Japan Friendship Hospital

Beijing, , China

Countries

China

Other Identifiers

AK3280-2001

Identifier Type: -

Identifier Source: org_study_id