Phase 1b Double‑Blind Single‑Dose Study of ATI‑052 Assessing Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Adults with Mild‑to‑Moderate Asthma

A total of 6 participants were enrolled, comprising both female and male individuals diagnosed with Mild to Moderate Asthma. The age range of the cohort spanned approximately 3 to 4 years, and all subjects were classified as patients rather than healthy volunteers. The population included individuals considered vulnerable, reflecting the inclusion of a pediatric asthma demographic. Participants were selected on the basis of having a confirmed diagnosis of mild to moderate asthma and meeting general health criteria consistent with stable respiratory status. No specific information regarding diet, physical activity, or other lifestyle factors was provided, and the sponsor did not disclose additional inclusion or exclusion criteria.

The study is a Phase 1b, double-blind investigation evaluating the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of a single oral dose of ATI‑052 in adults with mild to moderate asthma. Participants are allocated in a randomized, placebo‑controlled manner and monitored over a total involvement period of approximately 8 weeks, encompassing a screening visit, a baseline visit on Day 0 for study drug administration, follow‑up assessments on Days 1, 7, 14, 28, and 56, and a final end‑of‑study visit on Day 56. The screening visit confirms eligibility criteria and obtains baseline measurements; subsequent visits assess adverse events, vital signs, lung function, and drug concentrations to characterize pharmacokinetic and pharmacodynamic profiles. Early termination may occur if a participant experiences a serious adverse event, fails to meet protocol compliance, withdraws consent, or if the investigator determines continuation is not in the participant’s best interest. The overall trial recruitment window is projected from March 18 2026 to December 9 2026.

No experimental medication, comparator, or other treatment details are provided in the source data.

In this phase 3 study enrolling individuals with mild to moderate asthma, efficacy assessments will be performed in accordance with the study protocol at designated visits throughout the treatment period.