A Phase I Study Evaluating Safety, Tolerability, PK and P... | NCT02073019

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

NCT02073019

Sponsor

BioLineRx, Ltd.

Status

Completed

Last Update Posted

Jul 31, 2015Estimated

Enrollment

33Actual

Phase

Phase 1

Conditions

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

Interventions

BL-8040
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Feb 25, 2014

First Submission Date that Met QC Criteria

Feb 25, 2014

First Posted Date

Feb 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2015

Last Update Posted Date

Jul 31, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BL-8040	Drug		Cohort A Cohort B Cohort C
Placebo

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided