Phase I Randomized, Double‑Blind, Placebo‑Controlled Study of Inhaled RO7616605 Assessing Safety and Activity in Healthy Volunteers and COPD Patients

The primary objective is to evaluate the safety and pharmacodynamic activity of the inhaled investigational agent RO7616605 in healthy volunteers and participants with Chronic Obstructive Pulmonary Disease.

The trial enrolled adult participants of both sexes, encompassing individuals classified under age‑range codes 3 and 4, and included both patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and healthy volunteers; the sponsor did not provide the total number of subjects. Selection criteria required a confirmed diagnosis of COPD or chronic bronchitis for patient cohorts, while healthy volunteers were required to be free of significant respiratory disease. Both female and male participants were eligible, and the study population was designated as a vulnerable group, reflecting inclusion of individuals who may have limited decision‑making capacity or other risk factors. No additional lifestyle restrictions or specific exclusion criteria were detailed in the provided information.

The study is a Phase 1 investigation evaluating the safety and pharmacologic activity of the inhaled investigational compound RO7616605 in healthy volunteers and individuals diagnosed with Chronic Obstructive Pulmonary Disease. The design employs a randomized, double-blind, controlled methodology with participants allocated to either the active drug or matching placebo. Recruitment is scheduled to commence on 17 August 2026 and conclude on 13 September 2029. After an initial screening visit to confirm eligibility, participants undergo a baseline assessment followed by the administration of the study medication. Subsequent scheduled visits are conducted to monitor vital signs, pulmonary function, adverse events, and laboratory parameters at predefined intervals, culminating in an end‑of‑study visit that includes final safety evaluations and study drug discontinuation. Participant involvement extends from the screening appointment through the final end‑of‑study assessment, with the total duration of individual participation determined by the study schedule. Early discontinuation of a participant may occur at the investigator’s discretion for safety concerns or protocol non‑compliance.