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
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
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Spain | Recruiting | 15 Apr 2026 | 64 |

