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

NCT07235163 | Not Yet Recruiting Phase 1

• 1 other identifier: C6341001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (10)

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

  Part A

  Baseline, approximately up to 5 months

• Number of Participants With Clinically Significant Laboratory Abnormalities

  Part A

  Baseline, approximately up to 5 months

• Number of Participants With Vital Sign Abnormalities

  Part A

  Baseline, approximately up to 5 months

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

  Part A

  Baseline, approximately up to 5 months

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

  Part A

  Baseline, approximately up to 5 months

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

  Part B

  Baseline, approximately up to 7 months

• Number of Participants With Clinically Significant Laboratory Abnormalities

  Part B

  Baseline, approximately up to 7 months

• Number of Participants with Vital Sign Abnormalities

  Part B

  Baseline, approximately up to 7 months

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

  Part B

  Baseline, approximately up to 7 months

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

  Part B

  Baseline, approximately up to 7 months

Secondary Outcomes (9)

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

  Predose (Day 1), approximately up to 5 months

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

  Predose (Day 1), approximately up to 5 months

• Maximum Observed Plasma Concentration (Cmax)

  Predose (Day 1), approximately up to 5 months

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  Predose (Day 1), approximately up to 5 months

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

  Predose (Day 1), approximately up to 5 months

Study Arms (14)

Part A: Cohort 1: single ascending dose (SAD)

EXPERIMENTAL

Dose A - Participants will receive PF-08065010 or placebo.

Drug: PF-08065010; Drug: Placebo

Part A: Cohort 2: single ascending dose (SAD)

EXPERIMENTAL

Dose B - Participants will receive PF-08065010 or placebo.

Drug: PF-08065010; Drug: Placebo

Part A: Cohort 3: single ascending dose (SAD)

EXPERIMENTAL

Dose C - Participants will receive PF-08065010 or placebo.

Drug: PF-08065010; Drug: Placebo

Part A: Cohort 4: single ascending dose (SAD)

EXPERIMENTAL

Dose D - Participants will receive PF-08065010 or placebo.

Drug: PF-08065010; Drug: Placebo

Part A: Cohort 5: single ascending dose (SAD)

EXPERIMENTAL

Dose E - Participants will receive PF-08065010 or placebo.

Drug: PF-08065010; Drug: Placebo

Part A: Cohort 6: single ascending dose (SAD)

EXPERIMENTAL

Dose F - Participants will receive PF-08065010 or placebo.

Drug: PF-08065010; Drug: Placebo

Part A: Cohort 7: single ascending dose (SAD)

EXPERIMENTAL

Dose G - Participants will receive PF-08065010 or placebo.

Drug: PF-08065010; Drug: Placebo

Part A: Cohort 8: single ascending dose (SAD)

EXPERIMENTAL

Optional Japanese Cohort dose to be determined - Participants will receive PF-08065010 or placebo.

Drug: PF-08065010; Drug: Placebo

Part A: Cohort 9: single ascending dose (SAD)

EXPERIMENTAL

Optional Chinese Cohort dose to be determined - Participants will receive PF-08065010 or placebo.

Drug: PF-08065010; Drug: Placebo

Part A: Cohort 10: single ascending dose (SAD)

EXPERIMENTAL

Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo.

Drug: PF-08065010; Drug: Placebo

Part A: Cohort 11: single ascending dose (SAD)

EXPERIMENTAL

Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo.

Drug: PF-08065010; Drug: Placebo

Part B: Cohort 12: multiple dose

EXPERIMENTAL

Dose F - Participants will receive PF-08065010 or placebo.

Drug: PF-08065010; Drug: Placebo

Part B: Cohort 13: multiple dose

EXPERIMENTAL

Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo.

Drug: PF-08065010; Drug: Placebo

Part B: Cohort 14: multiple dose

EXPERIMENTAL

Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo.

Drug: PF-08065010; Drug: Placebo

Interventions

PF-08065010 DRUG

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

Part A: Cohort 10: single ascending dose (SAD); Part A: Cohort 11: single ascending dose (SAD); Part A: Cohort 1: single ascending dose (SAD); Part A: Cohort 2: single ascending dose (SAD); Part A: Cohort 3: single ascending dose (SAD); Part A: Cohort 4: single ascending dose (SAD); Part A: Cohort 5: single ascending dose (SAD); Part A: Cohort 6: single ascending dose (SAD); Part A: Cohort 7: single ascending dose (SAD); Part A: Cohort 8: single ascending dose (SAD); Part A: Cohort 9: single ascending dose (SAD); Part B: Cohort 12: multiple dose; Part B: Cohort 13: multiple dose; Part B: Cohort 14: multiple dose

Placebo DRUG

Placebo which will be SC or IV

Part A: Cohort 10: single ascending dose (SAD); Part A: Cohort 11: single ascending dose (SAD); Part A: Cohort 1: single ascending dose (SAD); Part A: Cohort 2: single ascending dose (SAD); Part A: Cohort 3: single ascending dose (SAD); Part A: Cohort 4: single ascending dose (SAD); Part A: Cohort 5: single ascending dose (SAD); Part A: Cohort 6: single ascending dose (SAD); Part A: Cohort 7: single ascending dose (SAD); Part A: Cohort 8: single ascending dose (SAD); Part A: Cohort 9: single ascending dose (SAD); Part B: Cohort 12: multiple dose; Part B: Cohort 13: multiple dose; Part B: Cohort 14: multiple dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: April 13, 2026
• Primary Completion (Estimated): July 16, 2027
• Study Completion (Estimated): July 16, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share