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

NCT ID: NCT07235163

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-16

Study Completion Date

2027-04-22

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

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

Group Type EXPERIMENTAL

PF-08065010

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo which will be SC or IV

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

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

Group Type EXPERIMENTAL

PF-08065010

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo which will be SC or IV

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

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

Group Type EXPERIMENTAL

PF-08065010

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo which will be SC or IV

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

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

Group Type EXPERIMENTAL

PF-08065010

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo which will be SC or IV

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

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

Group Type EXPERIMENTAL

PF-08065010

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo which will be SC or IV

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

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

Group Type EXPERIMENTAL

PF-08065010

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo which will be SC or IV

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

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

Group Type EXPERIMENTAL

PF-08065010

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo which will be SC or IV

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

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

Group Type EXPERIMENTAL

PF-08065010

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo which will be SC or IV

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

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

Group Type EXPERIMENTAL

PF-08065010

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo which will be SC or IV

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

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

Group Type EXPERIMENTAL

PF-08065010

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo which will be SC or IV

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

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

Group Type EXPERIMENTAL

PF-08065010

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo which will be SC or IV

Part B: Cohort 12: multiple dose

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

Group Type EXPERIMENTAL

PF-08065010

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo which will be SC or IV

Part B: Cohort 13: multiple dose

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

Group Type EXPERIMENTAL

PF-08065010

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo which will be SC or IV

Part B: Cohort 14: multiple dose

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

Group Type EXPERIMENTAL

PF-08065010

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo which will be SC or IV

Interventions

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PF-08065010

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

Intervention Type DRUG

Placebo

Placebo which will be SC or IV

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

Phone: 1-800-718-1021

Email: [email protected]

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C6341001

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

Other Identifiers

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C6341001

Identifier Type: -

Identifier Source: org_study_id