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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073019
• Other study ID #: BL-8040.02
• Status: Completed
• Phase: Phase 1
• First received: February 25, 2014
• Last updated: July 30, 2015
• Start date: August 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: BioLineRx, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

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

Intervention

Drug:
• BL-8040

• Placebo

Locations

Country	Name	City	State
Israel	Hadassah Clinical Research Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
BioLineRx, Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with Adverse Events		Up to 7 days after treatment comletion	Yes