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

Study Overview

• Status: Completed
• Conditions: Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)
• Intervention / Treatment: Drug: Placebo; Drug: BL-8040

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BioLineRx, Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: February 25, 2014
• First Posted (ESTIMATE): February 27, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: BL-8040.02