NCT03651349

To Determine the Maximum Tolerated Dose (MTD) of HK-001 in Healthy Volunteers

A Phase I Study to Determine the Maximum Tolerated Dose (MTD) of HK-001 and to Evaluate Its Pharmacokinetic Profile in Healthy Volunteers

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Everfront Biotech Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	HK-001	HK-001 is synthesized by PharmaCore Biotech Co., Ltd. Synthetic (Z)-BP with high purity will be used in this proposed study.
DRUG	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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2018-08-29
• Last updated: 2025-02-26

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study