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

NCT02073019 | Completed Phase 1 DMC

• 1 other identifier: BL-8040.02
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of subjects with Adverse Events

  Up to 7 days after treatment comletion

Study Arms (3)

Cohort A

EXPERIMENTAL

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

Drug: BL-8040; Drug: Placebo

Cohort B

EXPERIMENTAL

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

Drug: BL-8040; Drug: Placebo

Cohort C

EXPERIMENTAL

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

Drug: BL-8040; Drug: Placebo

Interventions

BL-8040 DRUG

Cohort A; Cohort B; Cohort C

Placebo DRUG

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioLineRx, Ltd.: lead

Study Sites (1)

Hadassah Clinical Research Center

Jerusalem, Israel

Location

MeSH Terms

Interventions

4-fluorobenzoyl-TN-14003

Study Officials

• Arnon Aharon, MD

  BioLineRx, Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: February 27, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 31, 2015

Record last verified: 2015-07

Locations

IL (1)