HealthyPhase 1NCT07453784
Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet Formulation
A Phase 1 study testing Obefazimod 50 mg Capsule and Obefazimod Minitablet 50 mg in people with Healthy, run by Abivax S.A. at 1 site in United Kingdom.
Trial summary
The sponsor is developing a pediatric minitablet formulation as part of the overall pharmaceutical development strategy. In vitro dissolution and physiological-based bio-pharmaceutics modelling and simulation have been used to guide the development of the mini-tablet formulation to match the PK exposure of the adult… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Obefazimod 50 mg Capsule and Obefazimod Minitablet 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2026to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Aged 18 to 55 years inclusive at the time of signing informed consent
- Must agree to adhere to the contraception requirements.
- Healthy male or non-pregnant, non-lactating female participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG and laboratory safety tests without any clinically significant abnormalities
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- Weight ≥50 kg at screening Inclusion criteria.
Who cannot join
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator.
- History of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator
- Participants with a history of cholecystectomy or gall stones
- Participants with chronic or recurrent infection
- Participants who have tested positive for tuberculosis
- Participants with a history of shingles within the last two months
Show all 19Show fewer
- History of opportunistic infection while not on immunosuppressive therapy
- Part 2 only: Participant has a medical condition that may adversely affect taste or smell activity including but not limited to mouth ulcers, significant gum disease, and respiratory and/or sinus infection or cold
- Part 2 only: Participant does not agree to the consumption of, or has any known allergies to any of the food vehicles used in this study (applesauce, chocolate pudding, yogurt)
- Participants who have received any IMP (Investigational Medicinal Product) in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
- Participants who have previously been administered IMP in this study
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- Participants who are taking, or have taken, any prescribed or over-the-counter drug, hormone replacement therapy (HRT) or herbal remedies (other than up to 4 g of paracetamol per day and hormonal contraception) in the 14 days or 5 elimination half-lives, whichever is longer, before first IMP administration (see Section 11.4). Exceptions may apply, as determined by the investigator
- Having any vaccination or planned vaccination within 28 days before Day 1. Participants who received live vaccine within 3 months prior to screening and/or who are planning to receive such a vaccine during the study duration.
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and in females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
- Current smokers and those who have smoked within the last 12 months
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- Confirmed positive drugs of abuse test result at screening or admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Quotient Sciences
Nottingham, NG11 6JS
Philip Evans, 03303031000, recruitment@weneedyou.co.uk
Philip Evans, MBChB MRCS (Ed)
About this study
Official title: Two-Part, Open-Label Study to Evaluate Single Dose Pharmacokinetics of an Obefazimod Minitablet Formulation, Estimate the Relative Bioavailability of the Minitablet Formulation and to Evaluate Minitablet Palatability in Healthy Participants
The sponsor is developing a pediatric minitablet formulation as part of the overall pharmaceutical development strategy. In vitro dissolution and physiological-based bio-pharmaceutics modelling and simulation have been used to guide the development of the mini-tablet formulation to match the PK exposure of the adult capsule formulation. The study aims to investigate the relative bioavailability of the 50mg minitablet compared to the adult obefazimod 50 mg capsule in adult healthy volunteers.
Read the detailed description
This is a single center, open-label, two-part study in healthy male and female participants.
Part 1 of this study aims to investigate the PK properties of single dose of obefazimod 50 mg minitablet formulation and to identify a dose that provides systemic exposures (Cmax and AUC) comparable to that of the adult clinical obefazimod 50 mg capsule formulation.
In part 2, the minitablet formulation will be administered with a soft food vehicle (applesauce, yogurt or chocolate pudding or water) to investigate the relative bioavailability of the 50mg minitablet mixed with water or soft foods compared to the adult obefazimod 50 mg capsule administered with no vehicle.
- Conditions
- Healthy
- Being tested
- Obefazimod 50 mg Capsule, Obefazimod Minitablet 50 mg
- Keywords
- Healthy participants, obefazimod, minitablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obefazimod 50 mg CapsuleDrug
Adult formulation
Obefazimod Minitablet 50 mgDrug
Pediatric formulation
| Study group | Role | What they receive |
|---|---|---|
| Obefazimod 50 mg Capsule Adult Formulation | Experimental | Participants will receive a single oral dose of obefazimod Capsule administered with water Receives: Drug: Obefazimod 50 mg Capsule |
| Obefazimod Minitablet 50 mg | Experimental | Participants will receive a single oral dose of obefazimod Minitablet with either Apple sauce, Chocolate pudding, Yogurt, Water Receives: Drug: Obefazimod Minitablet 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Cmax of obefazimod in the Minitablet and Capsule regimens
Measured: Up to 336 hours post-dose (Day 15) at each period
Area under the plasma concentration versus time curve from time zero up to the last measurable concentration (AUC (0-last)
AUC (0-last) of obefazimod in the Minitablet and Capsule regimens
Measured: Up to 336 hours post-dose (Day 15) at each period
Area under the plasma concentration versus time curve up from time zero to infinity [AUC(0-inf)]
AUC(0-inf) of obefazimod in the Minitablet and Capsule regimens
Measured: Up to 336 hours post-dose (Day 15) at each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start3 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abivax S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453784
- Sponsor's protocol ID
- ABX464-911
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 6 Apr 2026
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Part, Open-Label Study to Evaluate Single Dose Pharmacokinetics of an Obefazimod Minitablet Formulation, Estimate the Relative Bioavailability of the Minitablet Formulation and to Evaluate Minitablet Palatability in Healthy Participants
- ClinicalTrials.gov ID
- NCT07453784
- Acronym / sponsor ID
- ABX464-911
- Conditions
- Healthy
- Keywords
- Healthy participants, obefazimod, minitablet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Abivax S.A.Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Mar 2026 (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.
The sponsor is developing a pediatric minitablet formulation as part of the overall pharmaceutical development strategy. In vitro dissolution and physiological-based bio-pharmaceutics modelling and simulation have been used to guide the development of the mini-tablet formulation to match the PK exposure of the adult capsule formulation. The study aims to investigate the relative bioavailability of the 50mg minitablet compared to the adult obefazimod 50 mg capsule in adult healthy volunteers.
Detailed description
This is a single center, open-label, two-part study in healthy male and female participants.
Part 1 of this study aims to investigate the PK properties of single dose of obefazimod 50 mg minitablet formulation and to identify a dose that provides systemic exposures (Cmax and AUC) comparable to that of the adult clinical obefazimod 50 mg capsule formulation.
In part 2, the minitablet formulation will be administered with a soft food vehicle (applesauce, yogurt or chocolate pudding or water) to investigate the relative bioavailability of the 50mg minitablet mixed with water or soft foods compared to the adult obefazimod 50 mg capsule administered with no vehicle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obefazimod 50 mg Capsule Adult Formulation | Experimental | Drug: Obefazimod 50 mg CapsuleParticipants will receive a single oral dose of obefazimod Capsule administered with water |
| Obefazimod Minitablet 50 mg | Experimental | Drug: Obefazimod Minitablet 50 mgParticipants will receive a single oral dose of obefazimod Minitablet with either Apple sauce, Chocolate pudding, Yogurt, Water |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 to 55 years inclusive at the time of signing informed consent
- Must agree to adhere to the contraception requirements.
- Healthy male or non-pregnant, non-lactating female participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG and laboratory safety tests without any clinically significant abnormalities
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- Weight ≥50 kg at screening Inclusion criteria.
Key exclusion criteria (19 listed)
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator.
- History of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator
- Participants with a history of cholecystectomy or gall stones
- Participants with chronic or recurrent infection
- Participants who have tested positive for tuberculosis
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 |
|---|---|---|
| Obefazimod 50 mg CapsuleAdult formulation | Drug | Obefazimod 50 mg Capsule Adult Formulation |
| Obefazimod Minitablet 50 mgPediatric formulation | Drug | Obefazimod Minitablet 50 mg |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: Up to 336 hours post-dose (Day 15) at each period
Cmax of obefazimod in the Minitablet and Capsule regimens
Area under the plasma concentration versus time curve from time zero up to the last measurable concentration (AUC (0-last)
Time frame: Up to 336 hours post-dose (Day 15) at each period
AUC (0-last) of obefazimod in the Minitablet and Capsule regimens
Area under the plasma concentration versus time curve up from time zero to infinity [AUC(0-inf)]
Time frame: Up to 336 hours post-dose (Day 15) at each period
AUC(0-inf) of obefazimod in the Minitablet and Capsule regimens
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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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.
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 Obefazimod 50 mg Capsule and Obefazimod Minitablet 50 mg in people with Healthy, run by Abivax S.A. at 1 site in United Kingdom.
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 5 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: looking for participants now, as of the sponsor's last update on 6 Apr 2026. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josianne Nitcheu (33781759766, josianne.nitcheu@abivax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) (time frame: Up to 336 hours post-dose (Day 15) at each period). The study lists 3 primary outcomes in all. 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 6 Apr 2026.