Safety and PharmacokineticPhase 1NCT06049147
Study to Assess the Safety and Tolerability of MBF-015 in Healthy Young Volunteers
A Phase 1 study testing MBF-015 4 mg oral capsule and MBF-015 16 mg oral capsule in people with Safety and Pharmacokinetic, run by Medibiofarma S.L. at 1 site in Spain.
Trial summary
This is a single center, randomised, double blind, placebo controlled clinical study to assess the safety and tolerability of MBF-015 in healthy volunteers.This clinical phase I trial is divided in two stages and involves, first, a single ascending dose (SAD) study in healthy young male volunteers and then a multiple… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Pharmacokinetic
- What is being tested?
- MBF-015 4 mg oral capsule and MBF-015 16 mg oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jul 2021to 24 Aug 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be included in the single dose study, subjects should meet all the following criteria at the screening visit:
- Healthy male subjects, 18-45 years (inclusive) of age at the time of enrolment.
- Body weight within normal range (Quetelet's index between 19 and 27) expressed as weight (kg) / height (m)2.
- Normal clinical records and physical examination.
- Laboratory tests (haematology and biochemistry) within the range of normal values, according to the Biochemistry laboratory reference values of the 'Hospital de la Santa Creu i Sant Pau'. Variations may be admitted according to the clinical criteria of the CIM-Sant Pau.
- Clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (SBP between 100-140 mm Hg/ Diastolic Blood Pressure (DBP) between 50-90 mm Hg / HR between 50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
Show all 19Show fewer
- Males should agree to abstain from sexual intercourse with a female partner or agree to use a condom with spermicide, in addition to having their female partner using some contraceptive measures as oral contraceptive drugs, intrauterine hormonal contraception, or cervical caps until 28 days post-administration.
- To be able to understand the nature of the study and comply with all their requirements.
- Free acceptance to participate in the study should be stated in an informed consent document signed by the volunteer which must be approved by the Clinical Research Ethic Committee (CREC).
- For the multiple dose study in healthy male and female volunteers, subjects meeting all the following inclusion criteria at screening visit:
- Healthy male and female subjects, 18-45 years (inclusive) of age at the time of enrolment.
- Body weight within normal range (Quetelet's index between 19 and 27) expressed as weight (kg) / height (m2).
- Normal clinical records and physical examination at screening and baseline.
- Laboratory tests (haematology, biochemistry and urinalysis) within the range of normal values, according to the laboratory reference values of the 'Hospital de la Santa Creu i Sant Pau'. Variations may be admitted according to the clinical criteria of the CIM-Sant Pau.
- Clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (SBP between 100-140 mm Hg/ DBP between 50-90 mm Hg / HR between 50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
- Males should agree to abstain from sexual intercourse with a female partner or agree to use a condom with spermicide, in addition to having their female partner using some contraceptive measures as oral contraceptive drugs, intrauterine hormonal contraception, or cervical caps until 28 days post-administration.
- To be able to understand the nature of the study and comply with all their requirements.
- Free acceptance to participate in the study by obtains signed informed consent form approved by the CREC.
- Females must be of non childbearing potential (i.e. surgically sterile) or have to use contraceptive measures ( non-hormonal) such as condom, diaphragm or cervical / vault caps with spermicide until 28 days post administration
Who cannot join
- For the single dose study and multiple dose study meeting any of the following criteria at screening visit will be excluded from entry into the study:
- History of alcohol dependence or drug abuse in the last 5 years or daily consumption of alcohol > 40 gr/day for men.
- Heavy consumer of stimulating beverages (>5 coffees, teas, chocolate or cola drinks per day) and grape juice.
- Background of idiosyncrasy, food intolerance, hypersensitivity or adverse reactions to any drug or Galenic form.
- Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
- Intake of any medication within 2 weeks prior taking the study treatment (except for use of paracetamol in short-term symptomatic treatments), including over-the-counter products (including natural food supplements, vitamins and medicinal plants products), or any enzymatic inductor or inhibitor within 3 months before the drug administration.
Show all 21Show fewer
- Positive serology for hepatitis B, C or HIV.
- Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological, neurological disease or other chronic diseases.
- History of psychiatric diseases or epileptic seizures.
- 12 lead ECG obtained at screening with PR interval ≥ 220 msec, QRS ≥120 msec and QTc ≥ 440 msec, bradycardia (<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval.
- Having undergone major surgery during the previous 6 months.
- Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc.) from 6 months prior to drug administration.
- Participation in other clinical trials during the previous 90 days (drug to drug period) in which an investigational drug or a commercially available drug was tested.
- Donation of blood during the 4 weeks preceding the drug administration.
- Severe or moderate acute illness 4 weeks before drug administration.
- Clinically significant abnormal laboratory values (as determined by the PI) at the screening evaluation.
- Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract
- Positive results of the drugs at screening period or 24h before starting treatment period. A minimum list of 6 drugs will be screened for inclusion: Amphetamines, Cocaine, Ethanol, Opiates, Cannabinoids and Benzodiazepines (positive results may be repeated at the discretion of the PI).
- Female with positive results from pregnancy test or breast-feeding (only in MAD stage)
- A positive Covid-19 diagnosis prior to admission to the hospital.
- A medical history of brain or spinal disease that would interfere with lumbar puncture, CSF circulation or safety assessment, including tumours or abnormalities by MRI or computed tomography (CT), subarachnoid hemorrhage, suggestion of raised intracranial pressure on MRI or ophthalmic examination, spinal stenosis or curvature, chiari malformation, hydrocephalus, syringomyelia, tethered spinal cord syndrome and connective tissue disorders such as Ehlers-Danlos syndrome and Marfan syndrome.
Trial locations and contacts
1 site in 1 country.
Spain1 site
CIM-Sant Pau Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
About this study
Official title: Randomized, Double Blind, Placebo Controlled "First-in-human" Study to Assess the Safety and Tolerability of Single Ascending Oral Doses and Multiple Oral Doses of MBF-015 in Healthy Young Volunteers
This is a single center, randomised, double blind, placebo controlled clinical study to assess the safety and tolerability of MBF-015 in healthy volunteers.This clinical phase I trial is divided in two stages and involves, first, a single ascending dose (SAD) study in healthy young male volunteers and then a multiple ascending dose (MAD) study in healthy young men and woman. MBF-118 is developed for the treatment of multiple sclerosis.
Read the detailed description
This clinical phase I trial is divided in two stages. The first stage will be a dose escalation study without therapeutic benefit, in which MBF-015 will be administered as single oral ascending dose to healthy young male volunteers. Up to four different rising doses will be tested (4 mg, 8 mg, 16 mg, 32 mg, 64 mg) in groups/cohorts of 8 participants. Thus, five groups/cohorts will participate. For each dose level/group, the participants will be randomized to active or placebo with 2 participants being randomly assigned to placebo and 6 to the active drug. First, one volunteer will receive active drug and another one will receive placebo (subgroup 1); after at least 72h of safety and tolerability assessment a second subgroup of 3 volunteers will receive 2 active drug and 1 placebo; after at least another 72h of safety and tolerability parameters assessment, a third subgroup of 3 volunteers will receive the active drug. After evaluation of safety parameters of corresponding dose level, the process will replicate one week afterwards in the following dosages.
The second stage will be a dose escalation study without therapeutic benefit, in which MBF-015 will be administered as single oral daily dose, during 5 days to young male and female healthy volunteers. Up to four different rising dose levels will be tested (8 mg, 16 mg, 32 mg, and 64 mg) in cohorts of 8 subjects that are randomised to active treatment and placebo (6:2) and divided into three subsequent treatment blocks, as described above in the first stage.
The pharmacokinetics profile of MBF-015 will be also assessed at each dose level tested of the Single ascending dose study and the multiple ascending dose study. The 64 mg SAD part will also be used to measure the product concentration in cerebrospinal fluid (CSF).
- Conditions
- Safety and Pharmacokinetic
- Being tested
- MBF-015 4 mg oral capsule, MBF-015 16 mg oral capsule, Placebo
- Keywords
- Histone deacetylase inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBF-015 4 mg oral capsuleDrug
MBF-015 oral capsules Histone deacetylase inhibitor
MBF-015 16 mg oral capsuleDrug
MBF-015 oral capsules Histone deacetylase inhibitor
PlaceboDrug
Hard gelatin capsules filled with cellulose microcrystalline
| Study group | Role | What they receive |
|---|---|---|
| MBF-015 4mg oral single dose | Experimental | Drug: MBF-015 oral single dose. MBF-015 4 mg strength hard gelatin capsules Receives: Drug: MBF-015 4 mg oral capsule |
| MBF-015 8 mg oral single dose | Experimental | Drug: MBF-015 oral single dose. Two 4 mg strength hard gelatin capsules Receives: Drug: MBF-015 4 mg oral capsule |
| MBF-015 16 mg oral single dose | Experimental | Drug: MBF-015 oral single dose. One 16 mg strength hard gelatin capsules Receives: Drug: MBF-015 16 mg oral capsule |
| MBF-015 32 mg oral single dose | Experimental | Drug: MBF-015 oral single dose. Two 16 mg strength hard gelatin capsules Receives: Drug: MBF-015 16 mg oral capsule |
| MBF-015 64 mg oral single dose | Experimental | Drug: MBF-015 oral single dose. Four 16 mg strength hard gelatin capsules Receives: Drug: MBF-015 16 mg oral capsule |
| MBF-015 8 mg oral multiple dose | Experimental | Drug: MBF-015 oral single daily dose during five days. Two 4 mg strength hard gelatin capsules Receives: Drug: MBF-015 4 mg oral capsule |
| MBF-015 16 mg oral multiple dose | Experimental | Drug: MBF-015 oral single daily dose during five days. One 16 mg strength hard gelatin capsules Receives: Drug: MBF-015 16 mg oral capsule |
| MBF-015 32 mg oral multiple dose | Experimental | Drug: MBF-015 oral single daily dose during five days. Two 16 mg strength hard gelatin capsules Receives: Drug: MBF-015 16 mg oral capsule |
| MBF-015 64 mg oral multiple dose | Experimental | Drug: MBF-015 oral single daily dose during five days. Four 16 mg strength hard gelatin capsules Receives: Drug: MBF-015 16 mg oral capsule |
| Placebo single dose | Placebo comparator | Placebo Hard gelatin capsules filled with cellulose microcrystalline. One single administration Receives: Drug: Placebo |
| Placebo multiple dose | Placebo comparator | Placebo Hard gelatin capsules filled with cellulose microcrystalline. Single daily dose during five days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse events
Classification based in the Medical Dictionary for Regulatory Activities (MedDRa) Adverse Events will be qualified according to the definitions and values stated in CTCAE version 5.0
Measured: Day 1 through Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start7 Jul 2021
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and PharmacokineticStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medibiofarma S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martinez, Principal investigator, CIM-Sant Pau Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049147
- Sponsor's protocol ID
- MBF-015CT-01
- Other IDs
- 2020-005318-16
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled "First-in-human" Study to Assess the Safety and Tolerability of Single Ascending Oral Doses and Multiple Oral Doses of MBF-015 in Healthy Young Volunteers
- ClinicalTrials.gov ID
- NCT06049147
- Acronym / sponsor ID
- MBF-015CT-01
- Conditions
- Safety and Pharmacokinetic
- Keywords
- Histone deacetylase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Medibiofarma S.L.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 21 Sep 2023 (actual)
- 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.
This is a single center, randomised, double blind, placebo controlled clinical study to assess the safety and tolerability of MBF-015 in healthy volunteers.This clinical phase I trial is divided in two stages and involves, first, a single ascending dose (SAD) study in healthy young male volunteers and then a multiple ascending dose (MAD) study in healthy young men and woman. MBF-118 is developed for the treatment of multiple sclerosis.
Detailed description
This clinical phase I trial is divided in two stages. The first stage will be a dose escalation study without therapeutic benefit, in which MBF-015 will be administered as single oral ascending dose to healthy young male volunteers. Up to four different rising doses will be tested (4 mg, 8 mg, 16 mg, 32 mg, 64 mg) in groups/cohorts of 8 participants. Thus, five groups/cohorts will participate. For each dose level/group, the participants will be randomized to active or placebo with 2 participants being randomly assigned to placebo and 6 to the active drug. First, one volunteer will receive active drug and another one will receive placebo (subgroup 1); after at least 72h of safety and tolerability assessment a second subgroup of 3 volunteers will receive 2 active drug and 1 placebo; after at least another 72h of safety and tolerability parameters assessment, a third subgroup of 3 volunteers will receive the active drug. After evaluation of safety parameters of corresponding dose level, the process will replicate one week afterwards in the following dosages.
The second stage will be a dose escalation study without therapeutic benefit, in which MBF-015 will be administered as single oral daily dose, during 5 days to young male and female healthy volunteers. Up to four different rising dose levels will be tested (8 mg, 16 mg, 32 mg, and 64 mg) in cohorts of 8 subjects that are randomised to active treatment and placebo (6:2) and divided into three subsequent treatment blocks, as described above in the first stage.
The pharmacokinetics profile of MBF-015 will be also assessed at each dose level tested of the Single ascending dose study and the multiple ascending dose study. The 64 mg SAD part will also be used to measure the product concentration in cerebrospinal fluid (CSF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| MBF-015 4mg oral single dose | Experimental | Drug: MBF-015 4 mg oral capsuleDrug: MBF-015 oral single dose. MBF-015 4 mg strength hard gelatin capsules |
| MBF-015 8 mg oral single dose | Experimental | Drug: MBF-015 4 mg oral capsuleDrug: MBF-015 oral single dose. Two 4 mg strength hard gelatin capsules |
| MBF-015 16 mg oral single dose | Experimental | Drug: MBF-015 16 mg oral capsuleDrug: MBF-015 oral single dose. One 16 mg strength hard gelatin capsules |
| MBF-015 32 mg oral single dose | Experimental | Drug: MBF-015 16 mg oral capsuleDrug: MBF-015 oral single dose. Two 16 mg strength hard gelatin capsules |
| MBF-015 64 mg oral single dose | Experimental | Drug: MBF-015 16 mg oral capsuleDrug: MBF-015 oral single dose. Four 16 mg strength hard gelatin capsules |
| MBF-015 8 mg oral multiple dose | Experimental | Drug: MBF-015 4 mg oral capsuleDrug: MBF-015 oral single daily dose during five days. Two 4 mg strength hard gelatin capsules |
| MBF-015 16 mg oral multiple dose | Experimental | Drug: MBF-015 16 mg oral capsuleDrug: MBF-015 oral single daily dose during five days. One 16 mg strength hard gelatin capsules |
| MBF-015 32 mg oral multiple dose | Experimental | Drug: MBF-015 16 mg oral capsuleDrug: MBF-015 oral single daily dose during five days. Two 16 mg strength hard gelatin capsules |
| MBF-015 64 mg oral multiple dose | Experimental | Drug: MBF-015 16 mg oral capsuleDrug: MBF-015 oral single daily dose during five days. Four 16 mg strength hard gelatin capsules |
| Placebo single dose | Placebo comparator | Drug: PlaceboPlacebo Hard gelatin capsules filled with cellulose microcrystalline. One single administration |
| Placebo multiple dose | Placebo comparator | Drug: PlaceboPlacebo Hard gelatin capsules filled with cellulose microcrystalline. Single daily dose during five days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- To be included in the single dose study, subjects should meet all the following criteria at the screening visit:
- For the multiple dose study in healthy male and female volunteers, subjects meeting all the following inclusion criteria at screening visit:
- Healthy male and female subjects, 18-45 years (inclusive) of age at the time of enrolment.
- Body weight within normal range (Quetelet's index between 19 and 27) expressed as weight (kg) / height (m2).
- Normal clinical records and physical examination at screening and baseline.
Key exclusion criteria (21 listed)
- For the single dose study and multiple dose study meeting any of the following criteria at screening visit will be excluded from entry into the study:
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 |
|---|---|---|
| MBF-015 4 mg oral capsuleMBF-015 oral capsules Histone deacetylase inhibitor | Drug | MBF-015 4mg oral single dose, MBF-015 8 mg oral multiple dose, MBF-015 8 mg oral single dose |
| MBF-015 16 mg oral capsuleMBF-015 oral capsules Histone deacetylase inhibitor | Drug | MBF-015 16 mg oral multiple dose, MBF-015 16 mg oral single dose, MBF-015 32 mg oral multiple dose, MBF-015 32 mg oral single dose, MBF-015 64 mg oral multiple dose, MBF-015 64 mg oral single dose |
| PlaceboHard gelatin capsules filled with cellulose microcrystalline | Drug | Placebo multiple dose, Placebo single dose |
Primary outcome
Number of Adverse events
Time frame: Day 1 through Day 8
Classification based in the Medical Dictionary for Regulatory Activities (MedDRa) Adverse Events will be qualified according to the definitions and values stated in CTCAE version 5.0
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 21 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Safety and Pharmacokinetic
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Not yet recruitingPhase 1
Pharmacokinetics, Safety and Tolerability of Single Sequential and Multiple Intravenous Infusions of Ulinastatin for Injection in Healthy Chinese Participants
Healthy Participants, Ulinastatin
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
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.
Martinez principal investigator
CIM-Sant Pau Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 MBF-015 4 mg oral capsule and MBF-015 16 mg oral capsule in people with Safety and Pharmacokinetic, run by Medibiofarma S.L. at 1 site in Spain.
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 19 inclusion and 21 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 Sep 2023. 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 Spain. 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?
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 Adverse events (time frame: Day 1 through Day 8). 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 Sep 2023.