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

A Phase I, Two Part Study Exploring the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effect of Ascending Doses of BL-8040 in Healthy Subjects.

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

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