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NCT Number: 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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male or female between 18 and 65 years of age
  • deemed to be healthy

Exclusion criteria

  • Evidence or history of clinically significant medical conditions.
  • 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).
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
  • A positive urine drug test.

Treatment and study plan

PF-08065010

Drug

Experimental Pfizer compound which will be subcutaneous (SC) or intravenous (IV).

Placebo

Drug

Placebo which will be SC or IV

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline, approximately up to 5 months

    Part A

  2. Number of Participants With Clinically Significant Laboratory Abnormalities

    Time frame: Baseline, approximately up to 5 months

    Part A

  3. Number of Participants With Vital Sign Abnormalities

    Time frame: Baseline, approximately up to 5 months

    Part A

  4. Number of Participants with Change from Baseline in Physical Exam (PE) Parameters

    Time frame: Baseline, approximately up to 5 months

    Part A

  5. Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters

    Time frame: Baseline, approximately up to 5 months

    Part A

  6. Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline, approximately up to 7 months

    Part B

  7. Number of Participants With Clinically Significant Laboratory Abnormalities

    Time frame: Baseline, approximately up to 7 months

    Part B

  8. Number of Participants with Vital Sign Abnormalities

    Time frame: Baseline, approximately up to 7 months

    Part B

  9. Number of Participants with Change from Baseline in Physical Exam (PE) Parameters

    Time frame: Baseline, approximately up to 7 months

    Part B

  10. Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters

    Time frame: Baseline, approximately up to 7 months

    Part B

Secondary outcomes

  1. Area Under the Plasma Concentration-time Profile from Time Zero to the Time of Last Quantifiable Concentration (AUClast)

    Time frame: Predose (Day 1), approximately up to 5 months

    Part A

  2. Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf)

    Time frame: Predose (Day 1), approximately up to 5 months

    Part A

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Predose (Day 1), approximately up to 5 months

    Part A

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Predose (Day 1), approximately up to 5 months

    Part A

  5. Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half.

    Time frame: Predose (Day 1), approximately up to 5 months

    Part A

  6. Area under the serum concentration time profile over the dosing interval of 28 days (AUCtau)

    Time frame: Predose (Day 1), approximately up to 7 months

    Part B

  7. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Predose (Day 1), approximately up to 7 months

    Part B

  8. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Predose (Day 1), approximately up to 7 months

    Part B

  9. Plasma Decay Half-Life (t1/2)

    Time frame: Predose (Day 1), approximately up to 7 months

    Part B

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 19, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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