A Study of AK3280 in Chinese Healthy Volunteers

Shanghai Ark Biopharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: AK3280

Study type: Interventional

Funder types: Industry

Identifiers

NCT04926116

AK3280-2001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 4 patient groups, including a placebo group

AK3280 Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: AK3280

AK3280 Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: AK3280

AK3280 Optional Cohort

Experimental group

Description:

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.

Treatment:

Drug: AK3280

Control Arm

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo