A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-08065010 in Healthy Adults
- Trial ID
- 2025-523759-76-01
- Protocol
- C6341001
- Sponsor
- Pfizer Inc.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the tolerability and pharmacokinetics of varying doses of PF-08065010 in healthy adults. Assessment of these parameters is essential for determining the safety profile and metabolic characteristics of the investigational product. No secondary objectives were identified.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both male and female individuals. The participants fall within the age range of 3 to 4 years. The population includes vulnerable groups. No information was provided regarding rheumatoid arthritis, systemic lupus erythematosus, or specific lifestyle considerations.
Plans and Procedures
This Phase 1 clinical trial is designed to evaluate the tolerability and pharmacokinetics of varying doses of PF-08065010 in healthy adults. The study utilizes a research methodology to assess how the study medicine acts within the body. The procedural sequence begins with a screening visit to determine eligibility. Subsequent follow-up visits are conducted to monitor physiological responses and safety parameters. The process concludes with an end-of-study visit. The total duration of participant involvement will be determined by the specific study protocol, and conditions for early termination may be implemented based on safety or clinical criteria.
Treatment
Efficacy
The assessment of efficacy in this clinical trial involves the evaluation of participants diagnosed with rheumatoid arthritis and systemic lupus erythematosus. Specific parameters or methodologies for measuring efficacy were not provided.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Belgium | Recruiting | 23 Apr 2026 | 100 |

