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To Determine the Maximum Tolerated Dose (MTD) of HK-001 in Healthy Volunteers
Sponsor: Everfront Biotech Co., Ltd.
Summary
Eligible subjects will receive either different dosages of HK-001 or placebo in a 3:1 ratio in 1 of the 7 dose cohorts. After single dose administration, followed by an independent Data and Safety Monitoring Board (DSMB) meeting for safety assessments (including the available plasma pharmacokinetic profile), the subjects will be allowed to receive (Z)-BP or placebo twice a day orally at the study site for 14 consecutive days and follow up on the 28th day after the last dose administration by a site visit. The study drugs (including placebo) will be administered at the study site by following the investigator's instructions to either perform blood sampling for pharmacokinetic evaluation or maximize the treatment compliance. There will be 7 cohorts and subjects will be randomized into cohorts consisting of 8 subjects each (6 active and 2 placebo controls per cohort). Dose cohorts will be escalated sequentially from low to high dose (50 mg, BID; 100 mg, BID; 150 mg, BID; 225 mg, BID; 300 mg, BID; 400 mg, BID; 525 mg, BID) by following a modified Fibonacci sequence, and based on the decision of an independent DSMB at a set time point. Following all subjects of a cohort complete the safety and PK evaluation after receiving the last dose administration, a cohort at the next dose level will be launched if the DSMB does not identify significant safety concerns after reviewing safety data and PK profiles.
Official title: A Phase I Study to Determine the Maximum Tolerated Dose (MTD) of HK-001 and to Evaluate Its Pharmacokinetic Profile in Healthy Volunteers
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2021-02-01
Completion Date
2026-06-30
Last Updated
2025-02-26
Healthy Volunteers
Yes
Conditions
Interventions
HK-001
HK-001 is synthesized by PharmaCore Biotech Co., Ltd. Synthetic (Z)-BP with high purity will be used in this proposed study.
Placebo control
In order to evaluate the safety and tolerability of HK-001 more accurately, a drug-free placebo control is planned to be utilized for the same administration route in this proposed trial. The placebo control that is identical in appearance, smell, weight, and excipients will be supplied by Everfront Biotech Inc.
Locations (1)
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, Taiwan, Taiwan