Systemic Lupus Erythematosus (SLE) Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• male or female between 18 and 65 years of age

• deemed to be healthy

Locations
Other Locations
Belgium
Pfizer Clinical Research Unit - Brussels
RECRUITING
Brussels
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2026-04-21
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 100
Treatments
Experimental: Part A: Cohort 3: single ascending dose (SAD)
Dose C - Participants will receive PF-08065010 or placebo.
Experimental: Part A: Cohort 8: single ascending dose (SAD)
Optional Japanese Cohort dose to be determined - Participants will receive PF-08065010 or placebo.
Experimental: Part A: Cohort 1: single ascending dose (SAD)
Dose A - Participants will receive PF-08065010 or placebo.
Experimental: Part A: Cohort 5: single ascending dose (SAD)
Dose E - Participants will receive PF-08065010 or placebo.
Experimental: Part A: Cohort 7: single ascending dose (SAD)
Dose G - Participants will receive PF-08065010 or placebo.
Experimental: Part A: Cohort 4: single ascending dose (SAD)
Dose D - Participants will receive PF-08065010 or placebo.
Experimental: Part A: Cohort 2: single ascending dose (SAD)
Dose B - Participants will receive PF-08065010 or placebo.
Experimental: Part A: Cohort 9: single ascending dose (SAD)
Optional Chinese Cohort dose to be determined - Participants will receive PF-08065010 or placebo.
Experimental: Part A: Cohort 6: single ascending dose (SAD)
Dose F - Participants will receive PF-08065010 or placebo.
Experimental: Part A: Cohort 10: single ascending dose (SAD)
Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo.
Experimental: Part A: Cohort 11: single ascending dose (SAD)
Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo.
Experimental: Part B: Cohort 12: multiple dose
Dose F - Participants will receive PF-08065010 or placebo.
Experimental: Part B: Cohort 13: multiple dose
Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo.
Experimental: Part B: Cohort 14: multiple dose
Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo.
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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