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Healthy volunteers needed to Taste-Test a new drug pill

NCT ID NCT07453784

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new, smaller minitablet version of the drug obefazimod in 44 healthy adults aged 18 to 55. The goal is to see how the body absorbs the minitablet compared to the current capsule and to check if the minitablet tastes okay. Participants will take a single dose and have their blood levels measured. This is not a treatment study—it helps develop a child-friendly pill form.

Why investors are watching

Abivax is testing a new minitablet version of its drug obefazimod in 44 healthy adults. The study checks whether the minitablet delivers the same drug levels as the existing capsule and whether people find it palatable. For a small company, this readout matters because a positive result supports a pediatric formulation, which could broaden the drug's use beyond adults.

If it works: If the minitablet matches the capsule's drug exposure and tastes acceptable, Abivax can advance it toward studies in children. That could expand the drug's market to pediatric patients, a meaningful step for a small-cap company.

If it fails: If the minitablet shows poor absorption or is unpalatable, Abivax may need to reformulate, delaying pediatric development. Phase 1 trials in healthy volunteers often fail to translate to later stages, so a setback here would not be unusual.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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

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As listed by the trial registrant

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How to take part

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  1. The study's own enquiry address

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  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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Contacts and locations

Locations

  • Quotient Sciences

    RECRUITING

    Nottingham, NG11 6JS, United Kingdom

    Contact Email: •••••@•••••

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