Healthy Clinical Trial
Official title:
A First-in-Human, Randomized, Double-Blind, Placebo Controlled, Single-Center Combined Single-Ascending Dose and Multiple-Ascending Dose, Parallel Groups, Study to Assess Safety, Tolerability and Pharmacokinetics of BL-1021 in Healthy Volunteers
The purpose of this study is to test the safety, tolerability and pharmacokinetics of BL-1021 in healthy volunteers. Subsequent clinical studies will be designed to test the safety and efficacy of BL-1021 in patients with neuropathic pain based on data obtained from the proposal trial described below.
A total of 32 subjects in the single-ascending phase and 24 subjects in the multiple
ascending phase, who have provided a written informed consent and comply with
inclusion/exclusion criteria will participate in the study in 4 different cohorts in the
first phase (cohorts A, B, C and D) and 3 different cohorts in the second phase (cohorts E,
F and G), each consisting of 8 subjects.
First part dosing:
Cohort A - 10 mg Cohort B - 20 mg Cohort C - 30 mg Cohort D - 40 mg
Second part dosing:
Cohort E - X mg (X shall be determined using the results of the 1st part) Cohort F - 2X mg
Cohort G - 4X mg
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
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