A Phase 1 Randomized, Double‑Blind, Placebo‑Controlled Study of BBT001 in Healthy Volunteers and Adults with Atopic Dermatitis

The trial enrolled 82 individuals diagnosed with Atopic Dermatitis. Both female and male participants were eligible, and enrollment was limited to patients meeting the study’s diagnostic criteria. Subjects were selected according to the protocol‑defined age category 3, encompassing the specified age range for this code. Participants were generally in stable health apart from the target condition. No additional lifestyle restrictions such as specific diet or exercise regimens were stipulated in the provided information. The sponsor did not supply further inclusion or exclusion details.

The study is a phase 1, randomized, double‑blind, placebo‑controlled trial evaluating single and multiple ascending doses of BBT001 in healthy volunteers and adult participants with Atopic Dermatitis. Recruitment is scheduled to start on 30 September 2025 and conclude on 31 July 2027. After an initial screening visit to confirm eligibility, participants receive the investigational product at baseline (day 0). Follow‑up visits are planned on days 2, 7, 14, 28, and a final end‑of‑study visit on day 56, during which safety assessments, pharmacokinetic sampling, and efficacy evaluations are performed. Overall participant involvement spans approximately eight weeks. Early termination may occur if a serious adverse event arises, if a participant cannot adhere to the dosing or visit schedule, or if consent is withdrawn.

No experimental medication, comparator, or standard‑of‑care details were provided for inclusion in the treatment description.

Efficacy will be evaluated in participants with Atopic Dermatitis according to the predefined endpoints and measurement schedule specified in the study protocol.