CancerPhase 1NCT05921916
Study to Assess the Safety and Tolerability of MBF-118 in Healthy Volunteers
A Phase 1 study testing MBF-118 oral capsules in people with Cancer, 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-118 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
- Cancer
- What is being tested?
- MBF-118 oral capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jul 2020to 6 Sep 2022
- 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 (m2).
- Normal clinical records and physical examination.
- Laboratory tests (hematology 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/ 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.
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- 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 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 (hematology, biochemistry and urianalysis) 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 g/day for men and >24g/day for women
- 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 Galenical 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.
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- Positive serology for hepatitis B, C or HIV.
- Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological disease or other chronic diseases.
- History of psychiatric diseases or epileptic seizures.
- 12 lead ECG obtained at screening with PR ≥ 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 diarrhea or conditions associated with total or partial obstruction of the urinary tract
- Positive results of the drugs at screening period or the day 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)
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
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-118 in Healthy Young Volunteers
This is a single center, randomised, double blind, placebo controlled clinical study to assess the safety and tolerability of MBF-118 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 cancer.
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-118 will be administered as single oral ascending dose to healthy young male volunteers. Up to four different rising doses will be tested (100 mg, 200 mg, 400 mg and 600 mg) in groups/cohorts of 8 participants. Thus, four 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 (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 4 volunteers will receive 3 active drug and 1 placebo. 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-118 will be administered as single oral daily dose, during 5 days to young male and female healthy volunteers. Up to three different rising dose levels will be tested (100 mg, 200 mg, and 400 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-118 will be also assessed at each dose level tested of the Single ascending dose study and the multiple ascending dose study.
- Conditions
- Cancer
- Being tested
- MBF-118 oral capsules, Placebo oral capsule
- Keywords
- PPAR gamma partial agonist, anti-inflammatory, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBF-118 oral capsulesDrug
MBF-118 oral capsules PPAR gamma receptor partial agonist
Placebo oral capsuleDrug
Placebo oral capsule solid microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| MBF-118 100mg oral single dose | Experimental | Drug: MBF-118 100mg oral capsules single dose Hard gelatin capsules Receives: Drug: MBF-118 oral capsules |
| MBF-118 200 mg oral single dose | Experimental | Drug: MBF-118 200mg oral capsules single dose Hard gelatin capsules Receives: Drug: MBF-118 oral capsules |
| MBF-118 400 mg oral single dose | Experimental | Drug: MBF-118 400mg oral capsules single dose Hard gelatin capsules Receives: Drug: MBF-118 oral capsules |
| MBF-118 100 mg oral multiple dose | Experimental | Drug: MBF-118 100mg oral capsules multiple dose. One single daily dose during five days.
Hard gelatin capsules Receives: Drug: MBF-118 oral capsules |
| MBF-118 200 mg oral multiple dose | Experimental | Drug: MBF-118 200mg oral capsules multiple dose. One single daily dose during five days.
Hard gelatin capsules Receives: Drug: MBF-118 oral capsules |
| MBF-118 400 mg oral multiple dose | Experimental | Drug: MBF-118 400mg oral capsules multiple dose. One single daily dose during five days.
Hard gelatin capsules Receives: Drug: MBF-118 oral capsules |
| Placebo oral single dose | Placebo comparator | Placebo: Hard gelatin capsules single dose Receives: Drug: Placebo oral capsule |
| Placebo oral multiple dose | Placebo comparator | Placebo: Hard gelatin capsules. One single daily dose during five days. Receives: Drug: Placebo oral capsule |
| MBF-118 600 mg oral single dose | Experimental | Drug: MBF-118 600mg oral capsules single dose Hard gelatin capsules Receives: Drug: MBF-118 oral capsules |
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 4.0
Measured: Day 1 through Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start3 Jul 2020
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Model description
- Single center, randomized, double-blind, placebo-controlled clinical study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medibiofarma S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joan Martinez, MD, 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
- NCT05921916
- Sponsor's protocol ID
- MBF-118CT-01
- Other IDs
- 2019-002967-80, 2019
- Status last verified
- Sep 2023
- First submitted
- 14 Jun 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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-118 in Healthy Young Volunteers
- ClinicalTrials.gov ID
- NCT05921916
- Acronym / sponsor ID
- MBF-118CT-01
- Conditions
- Cancer
- Keywords
- PPAR gamma partial agonist, anti-inflammatory, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Medibiofarma S.L.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 27 Jun 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-118 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 cancer.
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-118 will be administered as single oral ascending dose to healthy young male volunteers. Up to four different rising doses will be tested (100 mg, 200 mg, 400 mg and 600 mg) in groups/cohorts of 8 participants. Thus, four 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 (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 4 volunteers will receive 3 active drug and 1 placebo. 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-118 will be administered as single oral daily dose, during 5 days to young male and female healthy volunteers. Up to three different rising dose levels will be tested (100 mg, 200 mg, and 400 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-118 will be also assessed at each dose level tested of the Single ascending dose study and the multiple ascending dose study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
- Model description
- Single center, randomized, double-blind, placebo-controlled clinical study.
| Arm | Type | Receives |
|---|---|---|
| MBF-118 100mg oral single dose | Experimental | Drug: MBF-118 oral capsulesDrug: MBF-118 100mg oral capsules single dose Hard gelatin capsules |
| MBF-118 200 mg oral single dose | Experimental | Drug: MBF-118 oral capsulesDrug: MBF-118 200mg oral capsules single dose Hard gelatin capsules |
| MBF-118 400 mg oral single dose | Experimental | Drug: MBF-118 oral capsulesDrug: MBF-118 400mg oral capsules single dose Hard gelatin capsules |
| MBF-118 100 mg oral multiple dose | Experimental | Drug: MBF-118 oral capsulesDrug: MBF-118 100mg oral capsules multiple dose. One single daily dose during five days. Hard gelatin capsules |
| MBF-118 200 mg oral multiple dose | Experimental | Drug: MBF-118 oral capsulesDrug: MBF-118 200mg oral capsules multiple dose. One single daily dose during five days. Hard gelatin capsules |
| MBF-118 400 mg oral multiple dose | Experimental | Drug: MBF-118 oral capsulesDrug: MBF-118 400mg oral capsules multiple dose. One single daily dose during five days. Hard gelatin capsules |
| Placebo oral single dose | Placebo comparator | Drug: Placebo oral capsulePlacebo: Hard gelatin capsules single dose |
| Placebo oral multiple dose | Placebo comparator | Drug: Placebo oral capsulePlacebo: Hard gelatin capsules. One single daily dose during five days. |
| MBF-118 600 mg oral single dose | Experimental | Drug: MBF-118 oral capsulesDrug: MBF-118 600mg oral capsules single dose Hard gelatin capsules |
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:
- 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 (m2).
- Normal clinical records and physical examination.
- Laboratory tests (hematology 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.
Key exclusion criteria (19 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-118 oral capsulesMBF-118 oral capsules PPAR gamma receptor partial agonist | Drug | MBF-118 100 mg oral multiple dose, MBF-118 100mg oral single dose, MBF-118 200 mg oral multiple dose, MBF-118 200 mg oral single dose, MBF-118 400 mg oral multiple dose, MBF-118 400 mg oral single dose, MBF-118 600 mg oral single dose |
| Placebo oral capsulePlacebo oral capsule solid microcrystalline cellulose | Drug | Placebo oral multiple dose, Placebo oral single dose |
Primary outcome
Number of Adverse events
Time frame: Day 1 through Day 5
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 4.0
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.
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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.
Joan Martinez, MD 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-118 oral capsules in people with Cancer, 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 19 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 5). 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.