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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Cohort 1: single ascending dose (SAD) | Experimental | Dose A - Participants will receive PF-08065010 or placebo. |
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| Part A: Cohort 2: single ascending dose (SAD) | Experimental | Dose B - Participants will receive PF-08065010 or placebo. |
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| Part A: Cohort 3: single ascending dose (SAD) | Experimental | Dose C - Participants will receive PF-08065010 or placebo. |
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| Part A: Cohort 4: single ascending dose (SAD) | Experimental | Dose D - Participants will receive PF-08065010 or placebo. |
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| Part A: Cohort 5: single ascending dose (SAD) | Experimental | Dose E - Participants will receive PF-08065010 or placebo. |
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| Part A: Cohort 6: single ascending dose (SAD) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08065010 | Drug | Experimental Pfizer compound which will be subcutaneous (SC) or intravenous (IV). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Profile from Time Zero to the Time of Last Quantifiable Concentration (AUClast) | Part A | Predose (Day 1), approximately up to 5 months |
| Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Experimental |
Dose F - Participants will receive PF-08065010 or placebo. |
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| Part A: Cohort 7: single ascending dose (SAD) | Experimental | Dose G - Participants will receive PF-08065010 or placebo. |
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| Part A: Cohort 8: single ascending dose (SAD) | Experimental | Optional Japanese Cohort dose to be determined - Participants will receive PF-08065010 or placebo. |
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| Part A: Cohort 9: single ascending dose (SAD) | Experimental | Optional Chinese Cohort dose to be determined - Participants will receive PF-08065010 or placebo. |
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| Part A: Cohort 10: single ascending dose (SAD) | Experimental | Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. |
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| Part A: Cohort 11: single ascending dose (SAD) | Experimental | Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. |
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| Part B: Cohort 12: multiple dose | Experimental | Dose F - Participants will receive PF-08065010 or placebo. |
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| Part B: Cohort 13: multiple dose | Experimental | Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. |
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| Part B: Cohort 14: multiple dose | Experimental | Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. |
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| Placebo | Drug | Placebo which will be SC or IV |
|
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 |
Part A |
| Predose (Day 1), approximately up to 5 months |
| Maximum Observed Plasma Concentration (Cmax) | Part A | Predose (Day 1), approximately up to 5 months |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Part A | 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. | Part A | Predose (Day 1), approximately up to 5 months |
| Area under the serum concentration time profile over the dosing interval of 28 days (AUCtau) | Part B | Predose (Day 1), approximately up to 7 months |
| Maximum Observed Plasma Concentration (Cmax) | Part B | Predose (Day 1), approximately up to 7 months |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Part B | Predose (Day 1), approximately up to 7 months |
| Plasma Decay Half-Life (t1/2) | Part B | Predose (Day 1), approximately up to 7 months |