A Study Intended to Evaluate Safety, Tolerability and Pharmacokinetics (PK) Parameters of BL-1021
- Registration Number
- NCT01121380
- Lead Sponsor
- BioLineRx, Ltd.
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A - 10 mg BL-1021 - Cohort A - 10 mg 1021 - Cohort B - 20 mg BL-1021 - Cohort B - 20 mg 1021 - Cohort C - 40 mg 1021 - Cohort D - 80 mg 1021 - Cohort E - X mg 1021 Part 2, multiple dose. X shall be determined using the results of part 1. Cohort F - 2X mg BL-1021 Part 2, multiple dose. X shall be determined using the results of part 1. Cohort F - 2X mg 1021 Part 2, multiple dose. X shall be determined using the results of part 1. Cohort G - 4X mg BL-1021 Part 2, multiple dose. X shall be determined using the results of part 1. Cohort G - 4X mg 1021 Part 2, multiple dose. X shall be determined using the results of part 1. Placebo 1021 In each cohort there is a placebo arm Cohort C - 40 mg BL-1021 - Cohort D - 80 mg BL-1021 - Cohort E - X mg BL-1021 Part 2, multiple dose. X shall be determined using the results of part 1.
- Primary Outcome Measures
Name Time Method Incidence of adverse events Part 1 and 2
- Secondary Outcome Measures
Name Time Method Mean change from baseline in vital signs Part 1 and 2 Mean change from baseline in laboratory parameters Part 1 and 2 Cmax, Tmax, AUCT, AUCI, kel, T½ Part 1 and 2 Dose linearity of PK parameters part 1 and 2
Trial Locations
- Locations (1)
Hadassah Clinical Research Center (HCRC)
🇮🇱Jerusalem, Israel