A Study of AK3280 in Chinese Healthy Volunteers

NCT04926116 | Completed Phase 1 DMC

• 1 other identifier: AK3280-2001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects with Adverse Events (AEs)

  An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study medication, whether or not considered related to the study medication in this clinical trial.

  From baseline up to approximately 6 weeks

Secondary Outcomes (18)

• Maximum Observed Plasma Concentration (Cmax) of AK3280

  Day1/Day17(pre-dose and 0.5,1,1.5,2,2.5,3,4,6,8,12hours post-dose), Day2/Day18(24hours post-dose), Day3/Day19(48hours post-dose), Day4/Day20(72hours post-dose); and Days6,8,10,14,15,16 (pre-dose)

• Maximum Observed Plasma Concentration (Cmax) of AK3280 Metabolite

  Day1/Day17(pre-dose and 0.5,1,1.5,2,2.5,3,4,6,8,12hours post-dose), Day2/Day18(24hours post-dose), Day3/Day19(48hours post-dose), Day4/Day20(72hours post-dose); and Days6,8,10,14,15,16 (pre-dose)

• Observed trough plasma concentration at end of dosing interval (Ctrough) of AK3280

  Day1/Day17(pre-dose and 0.5,1,1.5,2,2.5,3,4,6,8,12hours post-dose), Day2/Day18(24hours post-dose), Day3/Day19(48hours post-dose), Day4/Day20(72hours post-dose); and Days6,8,10,14,15,16 (pre-dose)

• Observed trough plasma concentration at end of dosing interval (Ctrough) of AK3280 Metabolite

  Day1/Day17(pre-dose and 0.5,1,1.5,2,2.5,3,4,6,8,12hours post-dose), Day2/Day18(24hours post-dose), Day3/Day19(48hours post-dose), Day4/Day20(72hours post-dose); and Days6,8,10,14,15,16 (pre-dose)

• Measure maximum plasma concentration at steady state (Css max) of AK3280

  Day1/Day17(pre-dose and 0.5,1,1.5,2,2.5,3,4,6,8,12hours post-dose), Day2/Day18(24hours post-dose), Day3/Day19(48hours post-dose), Day4/Day20(72hours post-dose); and Days6,8,10,14,15,16 (pre-dose)

Study Arms (4)

AK3280 Cohort 1

EXPERIMENTAL

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.

Drug: AK3280

AK3280 Cohort 2

EXPERIMENTAL

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.

Drug: AK3280

AK3280 Optional Cohort

EXPERIMENTAL

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.

Drug: AK3280

Control Arm

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

AK3280 DRUG

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

AK3280 Cohort 1; AK3280 Cohort 2; AK3280 Optional Cohort

Placebo DRUG

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

Control Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ark Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, 100029, China

Location

Study Officials

• Jimmy Gu

  info@arkbiosciences.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 14, 2021
• Study Start: June 9, 2021
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)