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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
32
BL-1021 is an orally available NCE which contains an elongated aliphatic side-chain. Dosage: Part 1 - Single Dose: 1 dose on Day 1, dosage will be 10, 20, 40 \& 80 mg according the cohort Part 2 - Multiple Dosing: up to 7 once-daily administrations. Dosage will be determined according the first part results.
1021
Hadassah Clinical Research Center (HCRC)
Jerusalem, Israel
Incidence of adverse events
Time frame: Part 1 and 2
Mean change from baseline in vital signs
Time frame: Part 1 and 2
Mean change from baseline in laboratory parameters
Time frame: Part 1 and 2
Cmax, Tmax, AUCT, AUCI, kel, T½
Time frame: Part 1 and 2
Dose linearity of PK parameters
Time frame: part 1 and 2
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