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

Pfizer

Status and phase: Begins enrollment this month; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: PF-08065010

Study type: Interventional

Funder types: Industry

Identifiers

NCT07235163

C6341001

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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100 participants in 14 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: PF-08065010

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: PF-08065010

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: PF-08065010

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: PF-08065010

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: PF-08065010

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: PF-08065010

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: PF-08065010

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: PF-08065010

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: PF-08065010

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: PF-08065010

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: PF-08065010

Drug: Placebo

Part B: Cohort 12: multiple dose

Experimental group

Description:

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

Treatment:

Drug: PF-08065010

Drug: Placebo

Part B: Cohort 13: multiple dose

Experimental group

Description:

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

Treatment:

Drug: PF-08065010

Drug: Placebo

Part B: Cohort 14: multiple dose

Experimental group

Description:

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

Treatment:

Drug: PF-08065010

Drug: Placebo