To evaluate the safety and tolerability of HL-300 ointment following single and multiple topical administrations in healthy Chinese adult volunteers.
This study is a single-center, randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase I clinical study in healthy volunteers. A total of 36 volunteers are planned to be enrolled, with 4 in Cohort 1, 8 in Cohort 2, and 12 in each of Cohort 3 and Cohort 4. In the single ascending dose (SAD) part (Cohorts 1-3), volunteers in each cohort will receive a single dose on Day 1 (D1). Blood samples will be collected from the volunteers at the time points specified in the protocol, and volunteers will be discharged after completing the final blood collection on D8. The blood sampling timepoints for subsequent dose cohorts may be adjusted based on the results of the preceding cohorts. In the multiple ascending dose (MAD) part (Cohort 4), volunteers will apply the study drug twice daily from D1 to D7 (the dosing frequency during the MAD period may be appropriately adjusted based on the PK characteristics of the single dose). Blood sampling timepoints will be adjusted based on the dosing results, and volunteers will be discharged to enter the safety follow-up period after completing the final blood collection. Volunteers in different dose cohorts will be enrolled sequentially, and the next cohort will only proceed provided that the 7-day tolerability evaluation of the preceding cohort indicates safety and tolerability. Whether to add subsequent dose cohorts will be determined based on the results obtained from the completed dose cohorts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Change from Baseline in Complete Blood Count
Time frame: Single dose: Day3 Day 8;Multiple dose: Day7 Day14
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Change from Baseline in Blood Biochemistry
Time frame: Single dose:Day3 Day 8;Multiple dose: Day7 Day14
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Change from Baseline in Coagulation Function
Time frame: Single dose:Day3, Day 8;Multiple dose: Day3, Day5, Day7, Day9, Day11, Day14
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Change from Baseline in Urinalysis
Time frame: Single dose:Day3 Day 8;Multiple dose: Day7 Day14
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Change from Baseline in U12-Lead Electrocardiogram (ECG)
Time frame: Single-dose: Pre-dose Day1,post-dose Day1-12hour , Day2, Day3, Day8. Multiple-dose: Pre-dose Day1, Day4, Day7,post-dose Day1-12hour , Day7-12hour, Day10, Day14.
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Change from Baseline in Physical Examination
Time frame: Single dose: Day 8; Multiple dose: Day7, Day14
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Number of Healthy Volunteers:12 (Treatment group: 10, Placebo: 2);Dosing Days:Day 1-Day 7, BID;