NCT07883226 A Phase 1 Multiple Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, Drug-Drug Interactions, and Pharmacokinetics of TBD11

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 66 participants in total. It began in 2026-10-21 with a primary completion date of 2027-05-30.

Brief Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose trial of TBD11 in healthy adults. It includes a dedicated open-label cohort in which TBD11 will be administered as a single dose with either a strong cytochrome P450 3A (CYP3A) inhibitor (itraconazole) or a strong CYP3A inducer (rifampicin) in 2 trial periods to evaluate DDI. The trial will consist of 3 cohorts; Cohort 1 will occur prior to Cohort 2 and Cohort 3. Cohort 2 and Cohort 3 will start after completion of Cohort 1 and will run in parallel. Cohort 1 will be double-blind and participants will receive 300 mg TBD11 or placebo once daily for 14 days. Cohort 2 will be the open-label DDI cohort. Cohort 3 will be double-blind and participants will receive TBD11 or placebo once daily for 84 days.

Eligibility Criteria

Inclusion Criteria: * 18 to 55 years of age, inclusive. * Healthy, as determined by the Investigator through medical history and clinical examination before enrolment. * Able to understand and comply with trial and site procedures, understand study risks, and provide written informed consent before any trial-specific procedure. * Able to complete all Screening evaluations and remain in the clinical research facility for required inpatient periods. * BMI between 18 and 32 kg/m², inclusive, and body weight of at least 50 kg at Screening. * Resting vital signs within protocol-defined ranges at Screening and Day -1. * 12-lead ECG consistent with normal cardiac conduction and function at Screening. * Non-smoker within the previous 90 days, with negative urine cotinine at Screening and no use of tobacco- or nicotine-containing products. * Screening clinical chemistry, coagulation, complete blood count, and urinalysis within laboratory reference ranges, unless assessed as not clinically significant by the Investigator/designee. * Negative HBsAg and HCV antibody at Screening. * Negative IGRA test for TB infection. * Negative HIV antibody test at Screening. * Negative urine drug screen and urine alcohol screen at Screening and Day -1. * For participants assigned female sex at birth: negative urine and serum pregnancy tests at Screening and non-childbearing potential as defined in the protocol. * For participants assigned male sex at birth who are not sterilized and sexually active with a female partner of childbearing potential: agreement to use condoms from Day -1 through 90 days after the last dose and not donate sperm during the trial and for 90 days after the last dose. Exclusion Criteria: * Current or past clinically significant cardiovascular, cerebrovascular, respiratory, gastrointestinal, haematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease. * Current or past condition expected to require treatment during the trial with medication known to inhibit or induce CYP3A4. * Clinically relevant cardiovascular disorder or symptoms suggestive of such disorder. * Prior history of TB infection or TB disease. * Current cough lasting more than 2 weeks, fever, night sweats, or unexplained weight loss. * Close household or repeated living/workspace contact with an individual with active TB in the preceding 12 months. * Active malignancy within 5 years of Screening, except basal cell or squamous cell skin cancers; any history of breast cancer or melanoma is exclusionary. * History of drug abuse within 1 year before Screening or use of specified hard drugs within 1 year before Screening, unless limited to prescribed opioid or amphetamine medication not currently being taken. * Surgical or medical condition that may alter absorption, metabolism, or excretion of trial treatment. * Use of prohibited medications, vitamins, dietary supplements, herbal products, or vaccination within the protocol-defined windows. * Contraindication to trial interventions or excipients, or clinically significant allergic/anaphylactic reaction to any medication. * Participation in another investigational drug, vaccine, or device study within 30 days or 5 half-lives, whichever is longer, before Screening and during this trial. * Any condition that may interfere with informed consent, compliance, interpretation of results, or place the participant at undue risk. * Blood donation within 2 months before Screening or planned blood donation during the trial or within 12 weeks after the final visit.

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