Healthy
Conditions
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 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.
Interventions
DRUGPF-08065010
Experimental Pfizer compound which will be subcutaneous (SC) or intravenous (IV).
DRUGPlacebo
Placebo which will be SC or IV
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline, approximately up to 5 months | Part A |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Baseline, approximately up to 5 months | Part A |
| Number of Participants With Vital Sign Abnormalities | Baseline, approximately up to 5 months | Part A |
| Number of Participants with Change from Baseline in Physical Exam (PE) Parameters | Baseline, approximately up to 5 months | Part A |
| Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters | Baseline, approximately up to 5 months | Part A |
| Number of Participants with Vital Sign Abnormalities | Baseline, approximately up to 7 months | Part B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-time Profile from Time Zero to the Time of Last Quantifiable Concentration (AUClast) | Predose (Day 1), approximately up to 5 months | Part A |
| Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf) | Predose (Day 1), approximately up to 5 months | Part A |
| Maximum Observed Plasma Concentration (Cmax) | Predose (Day 1), approximately up to 5 months | Part A |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Predose (Day 1), approximately up to 5 months | Part A |
| 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 5 months | Part A |
| Area under the serum concentration time profile over the dosing interval of 28 days (AUCtau) | Predose (Day 1), approximately up to 7 months | Part B |
| Plasma Decay Half-Life (t1/2) | Predose (Day 1), approximately up to 7 months | Part B |
Countries
Belgium
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed