Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)Phase 1NCT02073019
A Phase I Study Evaluating Safety, Tolerability, PK and PD of BL-8040 for Stem Cell Mobilization in Healthy Volunteers
A Phase 1 study testing BL-8040 in people with Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB), run by BioLineRx, Ltd. at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)
- What is being tested?
- BL-8040
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2014to Jul 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- BL-8040, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-8040Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion Receives: Drug: BL-8040; Drug: Placebo |
| Cohort B | Experimental | Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion Receives: Drug: BL-8040; Drug: Placebo |
| Cohort C | Experimental | Each subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion Receives: Drug: BL-8040; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Adverse Events
Measured: Up to 7 days after treatment comletion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioLineRx, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnon Aharon, MD, Study chair, BioLineRx, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073019
- Sponsor's protocol ID
- BL-8040.02
- Status last verified
- Jul 2015
- First submitted
- 25 Feb 2014
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02073019
- Acronym / sponsor ID
- BL-8040.02
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- BioLineRx, Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: BL-8040, Drug: PlaceboEach subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion |
| Cohort B | Experimental | Drug: BL-8040, Drug: PlaceboEach subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion |
| Cohort C | Experimental | Drug: BL-8040, Drug: PlaceboEach subject will receive a BL-8040 or Placebo on in a randomized double-blind fashion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-8040 | Drug | Cohort A, Cohort B, Cohort C |
| Placebo | Drug | Cohort A, Cohort B, Cohort C |
Primary outcome
Number of subjects with Adverse Events
Time frame: Up to 7 days after treatment comletion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnon Aharon, MD study chair
BioLineRx, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BL-8040 in people with Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB), run by BioLineRx, Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with Adverse Events (time frame: Up to 7 days after treatment comletion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.