A Study to Learn How Different Amounts of the Study Medicine Called PF-08065010 Are Tolerated and Act in the Body of Healthy Adults
Not Applicable
Not yet recruiting
- Conditions
- Healthy
- Interventions
- Drug: PF-08065010Drug: Placebo
- Registration Number
- NCT07235163
- Lead Sponsor
- Pfizer
- 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 3 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 5 months. During this time, they will stay at the study clinic for about 4 days each month and will have about 8 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
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- male or female between 18 and 65 years of age
- deemed to be healthy
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: Cohort 1: single ascending dose (SAD) PF-08065010 Dose A - Participants will receive PF-08065010 or placebo. Part A: Cohort 7: single ascending dose (SAD) PF-08065010 Dose G - Participants will receive PF-08065010 or placebo. Part A: Cohort 9: single ascending dose (SAD) PF-08065010 Optional Chinese Cohort dose to be determined - Participants will receive PF-08065010 or placebo. Part A: Cohort 11: single ascending dose (SAD) PF-08065010 Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. Part A: Cohort 11: single ascending dose (SAD) Placebo Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. Part B: Cohort 12: multiple dose PF-08065010 Dose F - Participants will receive PF-08065010 or placebo. Part B: Cohort 12: multiple dose Placebo Dose F - Participants will receive PF-08065010 or placebo. Part B: Cohort 13: multiple dose PF-08065010 Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. Part B: Cohort 13: multiple dose Placebo Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. Part B: Cohort 14: multiple dose PF-08065010 Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. Part B: Cohort 14: multiple dose Placebo Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. Part A: Cohort 1: single ascending dose (SAD) Placebo Dose A - Participants will receive PF-08065010 or placebo. Part A: Cohort 2: single ascending dose (SAD) PF-08065010 Dose B - Participants will receive PF-08065010 or placebo. Part A: Cohort 2: single ascending dose (SAD) Placebo Dose B - Participants will receive PF-08065010 or placebo. Part A: Cohort 4: single ascending dose (SAD) Placebo Dose D - Participants will receive PF-08065010 or placebo. Part A: Cohort 5: single ascending dose (SAD) PF-08065010 Dose E - Participants will receive PF-08065010 or placebo. Part A: Cohort 6: single ascending dose (SAD) PF-08065010 Dose F - Participants will receive PF-08065010 or placebo. Part A: Cohort 6: single ascending dose (SAD) Placebo Dose F - Participants will receive PF-08065010 or placebo. Part A: Cohort 8: single ascending dose (SAD) Placebo Optional Japanese Cohort dose to be determined - Participants will receive PF-08065010 or placebo. Part A: Cohort 10: single ascending dose (SAD) PF-08065010 Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. Part A: Cohort 10: single ascending dose (SAD) Placebo Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. Part A: Cohort 3: single ascending dose (SAD) PF-08065010 Dose C - Participants will receive PF-08065010 or placebo. Part A: Cohort 3: single ascending dose (SAD) Placebo Dose C - Participants will receive PF-08065010 or placebo. Part A: Cohort 4: single ascending dose (SAD) PF-08065010 Dose D - Participants will receive PF-08065010 or placebo. Part A: Cohort 5: single ascending dose (SAD) Placebo Dose E - Participants will receive PF-08065010 or placebo. Part A: Cohort 7: single ascending dose (SAD) Placebo Dose G - Participants will receive PF-08065010 or placebo. Part A: Cohort 8: single ascending dose (SAD) PF-08065010 Optional Japanese Cohort dose to be determined - Participants will receive PF-08065010 or placebo. Part A: Cohort 9: single ascending dose (SAD) Placebo Optional Chinese Cohort dose to be determined - Participants will receive PF-08065010 or placebo.
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline, approximately up to 5 months Part B
Number of Participants With Clinically Significant Laboratory Abnormalities Baseline, approximately up to 5 months Part B
Number of Participants With Vital Sign Abnormalities Baseline, approximately up to 3 months Part A
Number of Participants with Change from Baseline in Physical Exam (PE) Parameters Baseline, approximately up to 5 months Part B
Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters Baseline, approximately up to 5 months Part B
Number of Participants with Vital Sign Abnormalities Baseline, approximately up to 5 months Part B
- Secondary Outcome Measures
Name Time Method Area Under the Plasma Concentration-time Profile from Time Zero to the Time of Last Quantifiable Concentration (AUClast) Predose (Day 1), approximately up to 3 months Part A
Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf) Predose (Day 1), approximately up to 3 months Part A
Maximum Observed Plasma Concentration (Cmax) Predose (Day 1), approximately up to 5 months Part B
Time to Reach Maximum Observed Plasma Concentration (Tmax) Predose (Day 1), approximately up to 5 months Part B
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 3 months Part A
Area under the serum concentration time profile over the dosing interval of 28 days (AUCtau) Predose (Day 1), approximately up to 5 months Part B
Plasma Decay Half-Life (t1/2) Predose (Day 1), approximately up to 5 months Part B