A Phase I Study to Evaluate the Safety and Pharmacokinetics of RO7763505 in Healthy Volunteers and Patients with Stable Coronary Artery Disease
- Trial ID
- 2025-524693-42-00
- Protocol
- BP46355
- Sponsor
- F. Hoffmann-La Roche AG
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the safety and pharmacokinetics of RO7763505 in healthy volunteers and individuals with stable coronary artery disease. Assessing these parameters is essential to determine the tolerability and metabolic profile of the investigational product in both healthy and patient populations. No secondary objectives were identified.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of both male and female subjects, including both healthy volunteers and patients. The cohort includes vulnerable individuals and encompasses specific age ranges. Participants are characterized by the presence of stable coronary artery disease.
Plans and Procedures
This Phase 1 clinical trial is designed to evaluate the efficacy and safety of RO7763505 in healthy volunteers and individuals with stable coronary artery disease. The research methodology involves a controlled study design to assess the pharmacological properties of the investigational product. The sequence of procedures begins with a screening visit to determine eligibility based on specific criteria. Following screening, participants will undergo scheduled study visits to monitor safety and physiological responses. The protocol concludes with an end-of-study visit. The total duration of participant involvement is determined by the protocol-defined follow-up period. Early termination from the study may occur if specific safety or medical conditions are met.
Treatment
Efficacy
The clinical trial is designed to evaluate efficacy in patients with stable coronary artery disease. The assessment of efficacy will be conducted according to the established study protocol.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
The Netherlands | Recruiting | 15 Mar 2026 | — |
Netherlands | — | — | 196 |

