A Phase I Study Evaluating Safety, Tolerability, PK and PD of BL-8040 for Stem Cell Mobilization in Healthy Volunteers

Phase 1

Completed

• Conditions: Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)
• Interventions: Drug: BL-8040; Drug: Placebo

• Registration Number: NCT02073019
• Lead Sponsor: BioLineRx, Ltd.

Brief Summary

The purpose of this study is to determine whether BL-8040 is safe, tolerable and effective in the mobilization of Hematopoietic Stem Cells (HSC) in healthy volunteers

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-27
• Study Start: 2014-08
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-30
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

Inclusion Criteria

• Healthy male subjects
• BMI between 18 and 30 kg/m2 and Weight ≥ 60 Kg
• Subjects must be either surgically sterilized (vasectomy), or if their partner is of childbearing potential, must use two methods of contraception, one of which must be a barrier method, from the first dose until 3 months after the last dose
• Subject is able and willing to comply with the requirements of the protocol

Exclusion Criteria

• History of clinically significant disease
• Any illness within the 4 weeks prior to the screening examination
• Any history of alcohol and/or drug of abuse addiction and/or active / past (up to 2 years before screening) nicotine consumption
• Clinically relevant deviation from normal in the physical examination and vital signs at screening or baseline
• Clinically relevant laboratory abnormalities identified at screening or baseline
• Positive tests at screening for HIV I & II, hepatitis B and/or hepatitis C in both parts or positive tests for Syphilis, HTLV I & II and Nucleic Acid Test (NAT) for HIV and HBV
• Positive test for urine drugs of abuse or by anamnesis (Barbiturates, Benzodiazepines, Amphetamines, Opiates, Cocaine, Cannabinoids, Methadone, Phencyclidine, and Tricyclic Antidepressants) and/or positive alcohol blood test
• Subjects who have lost or donated in excess of 400 mL of blood within 3 months prior to Day 1 of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort C	BL-8040	Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion
Cohort A	BL-8040	Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion
Cohort B	BL-8040	Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion
Cohort C	Placebo	Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion
Cohort A	Placebo	Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion
Cohort B	Placebo	Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion

Primary Outcome Measures

Name	Time	Method
Number of subjects with Adverse Events	Up to 7 days after treatment comletion

Trial Locations

Locations (1)

Hadassah Clinical Research Center; 🇮🇱 Jerusalem, Israel