Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)
Conditions
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
Interventions
DRUGBL-8040
DRUGPlacebo
Sponsors
BioLineRx, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with Adverse Events | Up to 7 days after treatment comletion |
Countries
Israel
Outcome results
None listed