NCT07235163

A Study to Learn How Different Amounts of the Study Medicine Called PF-08065010 Are Tolerated and Act in the Body of Healthy Adults

AN INTERVENTIONAL, PHASE 1, RANDOMIZED STUDY WITH DOUBLE-BLIND AND SPONSOR-OPEN, PLACEBO-CONTROLLED SINGLE AND MULTIPLE DOSE ESCALATION TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF PF-08065010 IN HEALTHY ADULT PARTICIPANTS

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08065010) for possible treatment of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). This study is seeking participants who are: * male or female between 18 and 65 years of age * deemed to be healthy Participants in this study will receive PF-08065010 or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-08065010 or placebo will be given as a shot (in the abdomen, thigh or back of the arms) or as an IV infusion in the arm (given directly into a vein) at the study clinic. In Part A, participants will take PF-08065010 or placebo only 1 time and will take part in this study for about 5 months. During this time, they will stay at the study clinic for about 9-10 days and will have about 6 more study visits at the study clinic. Participants in Part B of the study will take PF-08065010 or placebo once a month, for 3 months and will take part in this study for about 7 months. During this time, they will stay at the study clinic for about 4 days each month and will have about 6 more study visits at the study clinic. During study clinic stays and study visits, urine, blood samples, and physical exams will be done.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PF-08065010	Experimental Pfizer compound which will be subcutaneous (SC) or intravenous (IV).
DRUG	Placebo	Placebo which will be SC or IV

Timeline

• Start date: 2026-04-13
• Primary completion: 2027-07-16
• Completion: 2027-07-16
• First posted: 2025-11-19
• Last updated: 2026-03-19