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

Study Overview
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Brief Summary
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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

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

Conditions
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Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)

Intervention / Treatment
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* Drug: BL-8040
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br>Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion | Drug: BL-8040<br> <br> Drug: Placebo<br> <br> |
| Experimental: Cohort B<br>Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion | Drug: BL-8040<br> <br> Drug: Placebo<br> <br> |
| Experimental: Cohort C<br>Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion | Drug: BL-8040<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Adverse Events |  | Up to 7 days after treatment comletion |