assignment
Recruiting

Randomized, Double‑Blind, Single‑ and Multiple‑Ascending Dose Study of S072 Assessing Safety and Tolerability in Healthy Adults for Treatment of Pain

Trial ID
2025-525039-15-01

Trial statistics

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investigator

Diseases & Conditions

Objectives

The primary objective is to assess the safety and tolerability of single and multiple ascending doses of S072 in healthy adult participants, providing critical data on adverse event incidence, severity, and dose‑related trends to inform subsequent clinical development for the treatment of pain.

Participants

The sponsor did not provide information on the total number of participants. The trial enrolment comprised both female and male individuals classified as Healthy volunteers, with the age range not specified in the available data. Subjects were selected without detailed description of recruitment methods, and the only reported medical condition was Pain. No additional lifestyle factors, such as diet or physical activity, or specific inclusion or exclusion criteria were disclosed.

Plans and Procedures

The study is a Phase 1, first‑in‑human tolerance investigation of single and multiple oral doses of S072 administered to healthy adult participants. After an initial screening visit to confirm eligibility, participants receive the assigned dose and undergo scheduled follow‑up visits for safety assessments, laboratory evaluations, and pharmacokinetic sampling. The trial includes a final end‑of‑study visit to complete safety monitoring and study procedures. Participant involvement spans from the screening appointment through the end‑of‑study visit, encompassing the dosing period and subsequent follow‑up assessments over several weeks. The overall recruitment period is projected from 15 April 2026 to 1 April 2028, and early termination of individual participation may occur if predefined safety or protocol criteria are met. The primary clinical condition under investigation is pain.

Treatment

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Trial Status by Country

Country Status Start of Recruitment Planned Patients
Spain SpainRecruiting15 Apr 202664

Sites & Investigators

Conditions Studied in This Trial