Phase 1 Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet Formulation

NCT07453784 | Not Yet Recruiting Phase 1

• 1 other identifier: ABX464-911
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy

Keywords

Healthy participants; obefazimod; minitablet

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax)

  Cmax of obefazimod in the Minitablet and Capsule regimens

  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

  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

  Up to 336 hours post-dose (Day 15) at each period

Study Arms (2)

Obefazimod 50 mg Capsule Adult Formulation

EXPERIMENTAL

Participants will receive a single oral dose of obefazimod Capsule administered with water

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

Drug: Obefazimod Minitablet 50 mg

Interventions

Obefazimod 50 mg Capsule DRUG

Adult formulation

Obefazimod 50 mg Capsule Adult Formulation

Obefazimod Minitablet 50 mg DRUG

Pediatric formulation

Obefazimod Minitablet 50 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abivax S.A.: lead
• Quotient Sciences: collaborator

Study Sites (1)

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Location

Central Study Contacts

Josianne Nitcheu

CONTACT

33781759766; josianne.nitcheu@abivax.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)