Testing different doses of PF-08065010 in healthy adults
Official title: 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
Run by Pfizer · NCT07235163 · Data updated 2026-11-12
This study tests whether PF-08065010 is safe and how it behaves in the body, comparing it to a placebo in healthy adults aged 18 to 65.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Brussels, Bruxelles-capitale, Région de) |
| Status | Recruiting |
| Started | April 21, 2026 |
| Main results expected | September 1, 2027 |
| Study ends | September 1, 2027 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT07235163 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18–65 without significant medical conditions who consent to participate and comply with study procedures.
✕Probably not a fit
Healthy volunteers without autoimmune disease may not gain direct therapeutic benefit from PF-08065010.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase study investigates the safety, tolerability, and pharmacology of PF-08065010 across two parts. Part A involves a single dose with in-clinic monitoring over about five months, including multiple visits. Part B assesses repeated monthly dosing for three months, with ongoing follow-up. Participants receive either PF-08065010 or placebo by injection or IV infusion at a Pfizer clinic in Brussels, under strict eligibility and safety monitoring.
Why it matters
Potential benefit: If safe and well-tolerated, findings could guide dosing for future studies in autoimmune conditions.
How similar studies have gone: Fewer data exist for PF-08065010 in healthy volunteers, making this a novel early-phase evaluation of safety and pharmacology.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * male or female between 18 and 65 years of age * deemed to be healthy Exclusion Criteria: 1. Evidence or history of clinically significant medical conditions. 2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg)or hepatitis C antibody (HCVAb). 3. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. 4. A positive urine drug test.
Where it's running
-
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium Recruiting
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.