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

BioLineRx

Status and phase: Completed; Phase 1

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

Treatments: Drug: BL-8040; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02073019

BL-8040.02

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

33 participants in 3 patient groups

Cohort A

Experimental group

Description:

Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion

Treatment:

Drug: Placebo

Drug: BL-8040

Cohort B

Experimental group

Description:

Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion

Treatment:

Drug: Placebo

Drug: BL-8040

Cohort C

Experimental group

Description:

Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion

Treatment:

Drug: Placebo

Drug: BL-8040