To Determine the Maximum Tolerated Dose (MTD) of HK-001 in Healthy Volunteers
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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.