First-in-Human, Randomized, Double‑Blind, Placebo‑Controlled Phase Ib Study of TIR‑C 2% Cutaneous Emulsion in Adults with Atopic Dermatitis

The primary objective is to evaluate the safety and tolerability of single and multiple doses of a 2% cutaneous emulsion of TIR‑C in adults with mild to moderate atopic dermatitis, establishing the adverse event profile and dose‑limiting toxicities. Secondary objectives include characterization of the pharmacokinetics of TIR‑C following single and repeat administration, and assessment of preliminary efficacy through measures of symptom control, changes in disease‑specific biomarkers, and patient‑reported quality‑of‑life outcomes.

The trial enrolled patients diagnosed with atopic dermatitis of both sexes; female and male participants were eligible. The age range was referenced by internal codes, but specific ages were not disclosed. The sponsor did not provide the total number of enrolled subjects. Selection was based on a diagnosis of the condition and classification as patients, with no further details on lifestyle factors such as diet or physical activity. No additional inclusion or exclusion criteria were detailed in the available information.

The study is a first‑in‑human, Phase Ib, double‑blind, randomised, placebo‑controlled trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of single and multiple doses of TIR‑C 2% cutaneous emulsion in adults with atopic dermatitis. Participants undergo an initial screening visit to confirm eligibility, followed by a baseline visit on Day 0 when the first dose is administered. Subsequent visits are scheduled at predetermined intervals (e.g., Days 7, 14, 28, and monthly thereafter) to assess safety parameters, collect pharmacokinetic samples, and evaluate clinical response. The end‑of‑study visit occurs approximately 12 weeks after the final dose to complete all assessments. Overall participant involvement spans roughly 12–16 weeks, depending on the dosing regimen. Early termination may occur if a participant experiences a serious adverse event, fails to meet compliance criteria, or withdraws consent. Recruitment is planned from September 2026 to June 2027.

No experimental medication, comparator, or standard‑of‑care treatments are specified in the provided source data.

Efficacy assessments will be conducted in accordance with the study protocol for participants with atopic dermatitis. The predefined efficacy parameters, measurement tools, and assessment schedule are specified in the protocol and will be applied consistently throughout the trial.