Healthy SubjectsPhase 1NCT05293171
Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects
A Phase 1 study testing 2 mg/kg BL-8040 and 400 mg Moxifloxacin (1x400 mg tablet) in people with Healthy Subjects, run by BioLineRx, Ltd. at 1 site in United States.
Trial summary
The study will assess the corrected QT (QTc) effects (electrocardiogram [ECG]) of motixafortide (BL-8040) 1.25 mg/kg (therapeutic dose) and 2 mg/kg (supratherapeutic dose) following a single subcutaneous (SC) injection relative to placebo in approximately 40 healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- 2 mg/kg BL-8040 and 400 mg Moxifloxacin (1x400 mg tablet)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2021to 15 Aug 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, males and females between the ages of 18 and 55 years, inclusive, at Screening.
- Body weight between 50-109 kg (inclusive) and body mass index (BMI) within 18.0-29.99 kg/m2 (inclusive) at Screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- Current non-smokers who have not used any nicotine-containing products (chewed or smoked) or replacement products including electronic cigarettes for at least 3 months prior to first dosing.
- Women must meet one of the following criteria: a) postmenopausal; b) surgically sterile; c) of childbearing potential and practicing contraception, as described below:
- Postmenopausal (postmenopausal women must have no menstrual bleeding for at least 1 year prior to first dosing and menopause is confirmed by follicle-stimulating (FSH) levels consistent with postmenopausal status), or
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- Surgically sterile (e.g., hysterectomy, bilateral oophorectomy, hysteroscopic sterilization) for at least 6 months prior to first dosing, or
- Women of childbearing potential must be non-lactating and agree to either using a highly effective acceptable form of birth control (e.g., non-hormonal intrauterine device plus condom and spermicide).
- A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after the last dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to the first dosing. A male who has been vasectomized less than 4 months prior to study first dosing must follow the same restrictions as a non-vasectomized male.)
- If male, must agree not to donate sperm from the first dosing until 90 days after the last dosing.
- Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.
Who cannot join
- Past or present diseases, which, as judged by the PI or designee, may affect the outcome of this study or pose an additional risk to the subject by their participation in the study, including, but not limited to, significant medical abnormality including: psychiatric, neurologic, pulmonary, cardiac, gastrointestinal, genitourinary, renal, metabolic, endocrinologic, or autoimmune disorder.
- Is mentally or legally incapacitated or has significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
- Positive result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at Screening.
- Family history of QTc prolongation or of unexplainable sudden death at <50 years of age.
- History or presence of any of the following:
- sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged Fridericia corrected QT (QTcF) interval, or conduction abnormalities;
Show all 40Show fewer
- ischemic heart disease, symptomatic arrhythmias, or poorly controlled hypertension.
- Knowledge of any kind of cardiovascular disorder/condition known to increase the possibility of QT prolongation or history of additional risk factors for torsade de pointes (e.g., heart failure, clinically significant hypokalemia, family history of Long QT Syndrome or Brugada Syndrome) or cardiac conduction disorders.
- Any condition that may interfere with the absorption, metabolism, or elimination of the study drug.
- History of, or active, alcohol or illicit drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, manual, within 2 years prior to the first dosing. Alcohol abuse is defined as an average intake of two or more drinks (12 oz beer, 1.5 oz of hard liquor, or equivalent) per day.
- Laboratory safety test results that are outside of the normal reference ranges (unless clinically acceptable to the PI or designee) at Screening.
- Resting supine heart rate (HR) <50 bpm or >100 bpm at Screening or check-in (Day -2). Minor deviations will be acceptable if considered to be of no clinical significance by the PI or designee.
- Resting supine systolic blood pressure <90 mmHg or >140 mmHg; resting supine diastolic blood pressure <50 mmHg or >90 mmHg at Screening or check-in.
- Significant history or presence of ECG findings at Screening or check-in (Day -2), including:
- QTcF >450 msec
- QRS >110 msec, if >110 msec, result will be confirmed by a manual over read
- PR >200 msec
- Second or third-degree atrioventricular (AV) block.
- Significant history or presence of ECG findings as judged by the PI or designee at
- Screening or check-in (Day -2), including:
- ECG abnormalities which interfere with accurate QT measurement
- T wave flattening or other abnormalities which in the opinion of the PI (or designee) may interfere with the analysis of QT intervals
- Any rhythm other than sinus rhythm, which is interpreted by the PI (or designee) to be clinically significant.
- Significant safety laboratory abnormalities that would place the subject at undue risk in the PI or designee's opinion, including but not limited to serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) >1.2 x upper limit of normal at Screening or check-in.
- Positive urine cotinine at Screening.
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days or 5 half-lives (whichever is longer) prior to the first dosing or likelihood that such treatment will be needed at any time during the study (unless approved in advance by the Sponsor). Medications listed in Section 11.4.2 will be allowed.
- Participation in another clinical study within 30 days prior to the first dosing. The 30-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.
- Donation of blood or blood loss >500 mL within the 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
- Any condition or situation that, in the opinion of the PI or designee, would prevent proper evaluation of the safety, PK, and/or PD of the study drug according to the study protocol (e.g., poorly compliant subject, poor venous access, allergies to medical plastics/latex/adhesive dressing/medical tape).
- History of hypersensitivity or allergy to moxifloxacin or any study medication.
- History of tendonitis or tendon rupture with moxifloxacin or any other quinolone type drug.
- History of unexplained loss of consciousness, unexplained syncope, near drowning with hospital admission.
- Use of any marijuana product within 6 months prior to the first dosing.
- Use of illicit drugs or tetrahydrocannabinol-containing medicines within 6 months prior to the first dosing.
- Female subjects with a positive pregnancy test at Screening or check-in or lactating.
- Positive urine drug or alcohol results at Screening or check-in.
- Has tattoo(s) or scarring at or near the site of injection or any other condition which may interfere with injection site examination, in the opinion of the PI or designee.
- Subjects intending to lose weight during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Positive-Controlled, Four-Way Crossover Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects
The study will assess the corrected QT (QTc) effects (electrocardiogram [ECG]) of motixafortide (BL-8040) 1.25 mg/kg (therapeutic dose) and 2 mg/kg (supratherapeutic dose) following a single subcutaneous (SC) injection relative to placebo in approximately 40 healthy subjects.
Read the detailed description
This is a randomized, double-blind (in respect to BL-8040 and BL-8040-matching placebo dosing), placebo- and positive-controlled, 4-period, 4-way crossover study in healthy subjects.
A continuous 12-lead cardiodynamic ECG recording will be collected for approximately 24 hours on Day -1 of Period 1 for use in the optimized individual corrected QTc (QTcI) baseline calculations.
On Day 1 of Period 1, subjects will be randomized to 1 of 12 treatment sequences. Each treatment sequence comprises 4 treatment periods.
On Day 1 of each period, subjects will receive single-dose SC injection of BL-8040 (therapeutic or supratherapeutic dose), single-dose SC injection of BL-8040-matching placebo, or a single oral dose of moxifloxacin. Cardiodynamic readings, plasma pharmacokinetic (PK) samples, and blood pharmacodynamic (PD) samples will be collected at different time points prior to dosing and up to 24 hours postdose in each period, as appropriate.
There will be a washout period of 5-7 days between dosing in each period.
All subjects who received at least one dose of any study drug (including subjects who terminate the study early) will return to the clinical research unit (CRU) 7 ± 2 days after the last dose for follow-up procedures, and to determine if any adverse event (AE) has occurred since the last study visit.
- Conditions
- Healthy Subjects
- Being tested
- 1.25 mg/kg BL-8040 + BL-8040-matching placebo, 2 mg/kg BL-8040, BL-8040-matching placebo, 400 mg Moxifloxacin (1x400 mg tablet)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.25 mg/kg BL-8040 + BL-8040-matching placeboDrug
Administered via subcutaneous (SC) injection
2 mg/kg BL-8040Drug
Administered via subcutaneous (SC) injection
BL-8040-matching placeboDrug
Administered subcutaneous (SC) injection
400 mg Moxifloxacin (1x400 mg tablet)Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 1.25 mg/kg BL-8040 + BL-8040-matching placebo administered via SC injection (Therapeutic) | Experimental | 1.25 mg/kg BL-8040 + BL-8040-matching placebo administered via SC injection (Therapeutic) Receives: Drug: 1.25 mg/kg BL-8040 + BL-8040-matching placebo |
| 2 mg/kg BL-8040 administered via SC injection (Supratherapeutic) | Experimental | 2 mg/kg BL-8040 administered via SC injection (Supratherapeutic) Receives: Drug: 2 mg/kg BL-8040 |
| BL-8040-matching placebo administered via SC injection | Placebo comparator | BL-8040-matching placebo administered via SC injection Receives: Drug: BL-8040-matching placebo |
| 400 mg moxifloxacin (1 x 400 mg tablet) administered orally | Active comparator | 400 mg moxifloxacin (1 x 400 mg tablet) administered orally Receives: Drug: 400 mg Moxifloxacin (1x400 mg tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
Assessment of the QTc effects of motixafortide 1.25 mg/kg and 2 mg/kg following a single SC injection relative to placebo in healthy subjects by evaluation of the relationship between the plasma concentration of motixafortide and ΔΔQTcI (change from baseline in QTcI)
Measured: Cardiodynamic ECG recordings on Day 1 (day of dosing) at different time points prior to dosing and up to 24 hours post-dose in each period (each period is 24 hours long, a total of 4 periods)
Secondary outcomes (6)
Evaluation of AEs, 12-lead Safety ECGs, Vital Signs, Clinical Laboratory Tests, and Physical Examinations.
Evaluation of safety (by assessing adverse events (AEs), ECGs, vital signs, clinical lab tests, physical examination) and tolerability (by assessing AEs) of single therapeutic and supratherapeutic SC injections of motixafortide in healthy subjects as well as of placebo and moxifloxacin.
Measured: During the entire study. For each participant starting from Screening until End of Study Visit - approximately 1 month.
PK (AUC0-t and AUC0-inf) of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) in Healthy Subjects.
Evaluation of pharmacokinetics (PK) (AUC0-t and AUC0-inf) of single therapeutic and supratherapeutic SC injections of motixafortide in healthy subjects.
Measured: Blood for motixafortide PK is collected prior to dosing and at 13 different timepoints following dosing up to 24 hours
PK (AUC%Extrap) of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) in Healthy Subjects.
Evaluation of PK (AUC%extrap) of single therapeutic and supratherapeutic SC injections of motixafortide in healthy subjects.
AUC%extrap = (1 - AUC0-t/AUC0-inf) x 100
Measured: Blood for motixafortide PK is collected prior to dosing and at 13 different timepoints following dosing up to 24 hours
PK (Cmax) of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) in Healthy Subjects.
Evaluation of PK (Cmax) of single therapeutic and supratherapeutic SC injections of motixafortide in healthy subjects.
Measured: Blood for motixafortide PK is collected prior to dosing and at 13 different timepoints following dosing up to 24 hours
PK (Tmax) of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) in Healthy Subjects.
Evaluation of PK (Tmax) of single therapeutic and supratherapeutic SC injections of motixafortide in healthy subjects.
Measured: Blood for motixafortide PK is collected prior to dosing and at 13 different time points following dosing up to 24 hours
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
Assessment of the effect of single therapeutic and supratherapeutic SC injections of motixafortide on Heart Rate (a non-QT interval ECG parameter) by change from baseline (in bpm).
"Change from Baseline" at the Baseline timepoint (predosing) is defined as zero.
Baseline was the average of the derived ECG intervals from the 3 ECG timepoints prior to dosing (-0.75, -0.5, and -0.25 hours) on Day 1.
Descriptive statistics of ECG parameters (HR) by-timepoint analysis of Change-from-Baseline values was done.
Measured: ECG recording from prior to dosing (3 timepoints) until 24 hours following administration (13 timepoints after dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start11 Jun 2021
- Primary completion1 Jun 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy SubjectsStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, double-blind (in respect to BL-8040 and BL-8040-matching placebo dosing), placebo- and positive-controlled, 4-period, 4-way crossover study. On Day 1 of Period 1, subjects will be randomized to 1 of 12 treatment sequences. Each treatment sequence comprises 4 treatment periods. Each subject will be assigned a unique identification number upon screening. Subjects who complete the study screening assessments and meet all the eligibility criteria will be assigned a unique randomization identification number at the time of the first dosing, different from the screening number, and will receive the corresponding study drug, according to a randomization scheme. Subjects will receive each of the 4 Treatments in a pre-defined order according to the sequence scheme determined at randomization.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioLineRx, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293171
- Sponsor's protocol ID
- BL-8040.TQT.103
- Status last verified
- Mar 2025
- First submitted
- 2 Feb 2022
- Last updated
- 21 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Positive-Controlled, Four-Way Crossover Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05293171
- Acronym / sponsor ID
- BL-8040.TQT.103
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- BioLineRx, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Posted 21 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess the corrected QT (QTc) effects (electrocardiogram [ECG]) of motixafortide (BL-8040) 1.25 mg/kg (therapeutic dose) and 2 mg/kg (supratherapeutic dose) following a single subcutaneous (SC) injection relative to placebo in approximately 40 healthy subjects.
Detailed description
This is a randomized, double-blind (in respect to BL-8040 and BL-8040-matching placebo dosing), placebo- and positive-controlled, 4-period, 4-way crossover study in healthy subjects.
A continuous 12-lead cardiodynamic ECG recording will be collected for approximately 24 hours on Day -1 of Period 1 for use in the optimized individual corrected QTc (QTcI) baseline calculations.
On Day 1 of Period 1, subjects will be randomized to 1 of 12 treatment sequences. Each treatment sequence comprises 4 treatment periods.
On Day 1 of each period, subjects will receive single-dose SC injection of BL-8040 (therapeutic or supratherapeutic dose), single-dose SC injection of BL-8040-matching placebo, or a single oral dose of moxifloxacin. Cardiodynamic readings, plasma pharmacokinetic (PK) samples, and blood pharmacodynamic (PD) samples will be collected at different time points prior to dosing and up to 24 hours postdose in each period, as appropriate.
There will be a washout period of 5-7 days between dosing in each period.
All subjects who received at least one dose of any study drug (including subjects who terminate the study early) will return to the clinical research unit (CRU) 7 ± 2 days after the last dose for follow-up procedures, and to determine if any adverse event (AE) has occurred since the last study visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- This is a randomized, double-blind (in respect to BL-8040 and BL-8040-matching placebo dosing), placebo- and positive-controlled, 4-period, 4-way crossover study. On Day 1 of Period 1, subjects will be randomized to 1 of 12 treatment sequences. Each treatment sequence comprises 4 treatment periods. Each subject will be assigned a unique identification number upon screening. Subjects who complete the study screening assessments and meet all the eligibility criteria will be assigned a unique randomization identification number at the time of the first dosing, different from the screening number, and will receive the corresponding study drug, according to a randomization scheme. Subjects will receive each of the 4 Treatments in a pre-defined order according to the sequence scheme determined at randomization.
| Arm | Type | Receives |
|---|---|---|
| 1.25 mg/kg BL-8040 + BL-8040-matching placebo administered via SC injection (Therapeutic) | Experimental | Drug: 1.25 mg/kg BL-8040 + BL-8040-matching placebo1.25 mg/kg BL-8040 + BL-8040-matching placebo administered via SC injection (Therapeutic) |
| 2 mg/kg BL-8040 administered via SC injection (Supratherapeutic) | Experimental | Drug: 2 mg/kg BL-80402 mg/kg BL-8040 administered via SC injection (Supratherapeutic) |
| BL-8040-matching placebo administered via SC injection | Placebo comparator | Drug: BL-8040-matching placeboBL-8040-matching placebo administered via SC injection |
| 400 mg moxifloxacin (1 x 400 mg tablet) administered orally | Active comparator | Drug: 400 mg Moxifloxacin (1x400 mg tablet)400 mg moxifloxacin (1 x 400 mg tablet) administered orally |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy, adult, males and females between the ages of 18 and 55 years, inclusive, at Screening.
- Body weight between 50-109 kg (inclusive) and body mass index (BMI) within 18.0-29.99 kg/m2 (inclusive) at Screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- Current non-smokers who have not used any nicotine-containing products (chewed or smoked) or replacement products including electronic cigarettes for at least 3 months prior to first dosing.
- Women must meet one of the following criteria: a) postmenopausal; b) surgically sterile; c) of childbearing potential and practicing contraception, as described below:
Key exclusion criteria (40 listed)
- Past or present diseases, which, as judged by the PI or designee, may affect the outcome of this study or pose an additional risk to the subject by their participation in the study, including, but not limited to, significant medical abnormality including: psychiatric, neurologic, pulmonary, cardiac, gastrointestinal, genitourinary, renal, metabolic, endocrinologic, or autoimmune disorder.
- Is mentally or legally incapacitated or has significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
- Positive result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at Screening.
- Family history of QTc prolongation or of unexplainable sudden death at <50 years of age.
- History or presence of any of the following:
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 |
|---|---|---|
| 1.25 mg/kg BL-8040 + BL-8040-matching placeboAdministered via subcutaneous (SC) injection | Drug | 1.25 mg/kg BL-8040 + BL-8040-matching placebo administered via SC injection (Therapeutic) |
| 2 mg/kg BL-8040Administered via subcutaneous (SC) injection | Drug | 2 mg/kg BL-8040 administered via SC injection (Supratherapeutic) |
| BL-8040-matching placeboAdministered subcutaneous (SC) injection | Drug | BL-8040-matching placebo administered via SC injection |
| 400 mg Moxifloxacin (1x400 mg tablet)Administered orally | Drug | 400 mg moxifloxacin (1 x 400 mg tablet) administered orally |
Primary outcome
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg
Time frame: Cardiodynamic ECG recordings on Day 1 (day of dosing) at different time points prior to dosing and up to 24 hours post-dose in each period (each period is 24 hours long, a total of 4 periods)
Assessment of the QTc effects of motixafortide 1.25 mg/kg and 2 mg/kg following a single SC injection relative to placebo in healthy subjects by evaluation of the relationship between the plasma concentration of motixafortide and ΔΔQTcI (change from baseline in QTcI)
6 secondary outcomes
Evaluation of AEs, 12-lead Safety ECGs, Vital Signs, Clinical Laboratory Tests, and Physical Examinations.
Time frame: During the entire study. For each participant starting from Screening until End of Study Visit - approximately 1 month.
PK (AUC0-t and AUC0-inf) of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) in Healthy Subjects.
Time frame: Blood for motixafortide PK is collected prior to dosing and at 13 different timepoints following dosing up to 24 hours
PK (AUC%Extrap) of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) in Healthy Subjects.
Time frame: Blood for motixafortide PK is collected prior to dosing and at 13 different timepoints following dosing up to 24 hours
PK (Cmax) of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) in Healthy Subjects.
Time frame: Blood for motixafortide PK is collected prior to dosing and at 13 different timepoints following dosing up to 24 hours
PK (Tmax) of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) in Healthy Subjects.
Time frame: Blood for motixafortide PK is collected prior to dosing and at 13 different time points following dosing up to 24 hours
Effect of Single Therapeutic and Supratherapeutic SC Injections of Motixafortide (BL-8040) on Heart Rate
Time frame: ECG recording from prior to dosing (3 timepoints) until 24 hours following administration (13 timepoints after dosing)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 2 mg/kg BL-8040 and 400 mg Moxifloxacin (1x400 mg tablet) in people with Healthy Subjects, run by BioLineRx, Ltd. at 1 site in United States.
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 11 inclusion and 40 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 21 Mar 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
QTc Effect of Single Subcutaneous (SC) Injections of Motixafortide (BL-8040) 1.25 mg/kg and 2 mg/kg (time frame: Cardiodynamic ECG recordings on Day 1 (day of dosing) at different time points prior to dosing and up to 24 hours post-dose in each period (each period is 24 hours long, a total of 4 periods)). 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 21 Mar 2025.