First-in-Human Study of BAY 3620122, a Novel Therapeutic for Vasodilatory Shock, Evaluating Safety, Pharmacokinetics, and Pharmacodynamics in Healthy Volunteers

The primary objective is to assess the safety and tolerability of single and multiple ascending doses of BAY 3620122 in healthy volunteers, establishing a risk profile relevant to future studies in vasodilatory shock.

Secondary objectives include:

• Characterization of the pharmacokinetic profile of BAY 3620122 (absorption, distribution, metabolism, and excretion).
• Evaluation of pharmacodynamic effects indicative of target engagement and vascular response.

The trial enrolled healthy volunteers of both sexes; however, the sponsor did not provide the total number of participants. The population was described as including males and females and classified under the “Healthy volunteers” group. The age range was indicated by code “3,” but the specific age limits were not disclosed. Participants were selected without reference to particular lifestyle factors such as diet or physical activity, and no detailed inclusion or exclusion criteria were provided. The medical condition of interest for the study was vasodilatory shock, but no further participant characteristics related to this condition were reported.

The study is a first‑in‑human, Phase 1 clinical trial evaluating the safety, pharmacokinetics, and pharmacodynamic effects of BAY 3620122 in healthy adult participants. Recruitment is scheduled to begin on 17 November 2025 and to finish by 2 November 2026, with each enrolled individual expected to remain in the trial for several weeks. The protocol includes an initial screening visit to verify eligibility, a baseline visit during which the investigational product is administered, followed by scheduled follow‑up visits for safety assessments and serial blood sampling to characterize drug absorption and systemic exposure. The sequence culminates in an end‑of‑study visit that completes all final evaluations. Participants may be withdrawn early in the event of a serious adverse event, inability to adhere to the dosing or visit schedule, or voluntary discontinuation. The trial enrolls only healthy volunteers and does not involve patients with vasodilatory shock.

Efficacy will be evaluated according to the predefined criteria specified in the study protocol.