A Study of AK3280 in Chinese Healthy Volunteers

Healthy Clinical Trial

Official title:

A Phase I Study to Evaluate The Safety, Tolerability, and Pharmacokinetics of AK3280 in Chinese Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04926116
• Other study ID #: AK3280-2001
• Status: Completed
• Phase: Phase 1
• Start date: June 9, 2021
• Est. completion date: September 28, 2021

Study information

• Verified date: April 2022
• Source: Ark Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 28, 2021
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Ark Biosciences Inc.	Shanghai Ark Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum Observed Plasma Concentration (Cmax) of AK3280	The maximum observed plasma concentration 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)
Secondary	Maximum Observed Plasma Concentration (Cmax) of AK3280 Metabolite	The maximum observed plasma concentration 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)
Secondary	Observed trough plasma concentration at end of dosing interval (Ctrough) of AK3280	The concentration of AK3280 reached immediately before the next dose administered.	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)
Secondary	Observed trough plasma concentration at end of dosing interval (Ctrough) of AK3280 Metabolite	The concentration of AK3280 metabolite reached immediately before the next dose administered.	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)
Secondary	Measure maximum plasma concentration at steady state (Css max) of AK3280	The maximum concentration of AK3280 reached at steady state.	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)
Secondary	Measure maximum plasma concentration at steady state (Css max) of AK3280 Metabolite	The maximum concentration of AK3280 metabolite reached at steady state.	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)
Secondary	Time to Maximum Plasma Concentration (Tmax) of AK3280	The time of occurrence of 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)
Secondary	Time to Maximum Plasma Concentration (Tmax) of AK3280 Metabolite	The time of occurrence of 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)
Secondary	Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of AK3280	The area under the plasma concentration-time curve from time zero up extrapolated to infinity 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)
Secondary	Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of AK3280 Metabolite	The area under the plasma concentration-time curve from time zero up extrapolated to infinity 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)
Secondary	Area under the plasma concentration-time curve from time zero up to 12hrs (AUC 0-12h) of AK3280	The area under the plasma concentration-time curve from time zero up to the 12hrs analytically quantifiable concentration of AK3280.	Day1/Day17(pre-dose and 0.5,1,1.5,2,2.5,3,4,6,8, and 12hours post-dose)
Secondary	Area under the plasma concentration-time curve from time zero up to 12hrs (AUC 0-12h) of AK3280 Metabolite	The area under the plasma concentration-time curve from time zero up to the 12hrs analytically quantifiable concentration of AK3280 metabolite.	Day1/Day17(pre-dose and 0.5,1,1.5,2,2.5,3,4,6,8, and 12hours post-dose)
Secondary	Terminal Half-Life (t1/2) of AK3280	The apparent elimination half-life 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)
Secondary	Terminal Half-Life (t1/2) of AK3280 Metabolite	The apparent elimination half-life 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)
Secondary	Apparent Oral Clearance (CL/F) of AK3280	The oral clearance 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)
Secondary	Apparent Oral Clearance (CL/F) of AK3280 Metabolite	The oral clearance 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)
Secondary	Apparent volume of distribution during terminal phase (Vz/F) of AK3280	The Vz/F of AK3280 will be calculated as CL/?z.	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)
Secondary	Apparent volume of distribution during terminal phase (Vz/F) of AK3280 Metabolite	The Vz/F of AK3280 metabolite will be calculated as CL/?z.	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)