A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body in Healthy Adults
Not Applicable
Not yet recruiting
- Conditions
- Healthy
- Interventions
- Drug: PF-07985631Drug: Placebo
- Registration Number
- NCT07235150
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-07985631) for the possible treatment of a kidney disease called IgA nephropathy.
This study is seeking participants who
* are male or female between 18 and 45 years of age (55 for Japanese/Chinese/multiple dose participants)
* are deemed to be healthy Participants in this study will receive PF-07985631 or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.
PF-07985631 or placebo will be given as a small needle injection (in the abdomen, thigh or back of the arm) at the study clinic. Most participants will receive PF-07985631 or placebo one time. Some participants may receive PF-07985631 or placebo twice.
The study will compare the experiences of people receiving PF-07985631 to those of the people who do not. This will help decide if PF-07985631 is safe and effective.
Participants who take PF-07985631 or placebo will take part in this study for about four- four and a half months. During this time, they will stay at the study clinic for 12 to 19 days and will have 7 more study visits at the study clinic.
During study clinic stays and study visits, blood samples will be done and safety reviews completed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 Dose A (3 active: 2 placebo) PF-07985631 Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be subcutaneous (SC) Cohort 1 Dose A (3 active: 2 placebo) Placebo Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be subcutaneous (SC) Cohort 2 Dose B (3 active: 2 placebo) PF-07985631 Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 2 Dose B (3 active: 2 placebo) Placebo Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 3 Dose C (6 active: 2 placebo) PF-07985631 Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 3 Dose C (6 active: 2 placebo) Placebo Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 4 Dose D (6 active: 2 placebo) PF-07985631 Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 5 Dose E (6 active: 2 placebo) PF-07985631 Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 5 Dose E (6 active: 2 placebo) Placebo Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 6 Dose F (6 active: 2 placebo) PF-07985631 Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 4 Dose D (6 active: 2 placebo) Placebo Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 7 Dose G (6 active: 2 placebo) Placebo Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 8 Optional Cohort with dose to be determined, Japanese (4 active: 1 placebo) PF-07985631 Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 8 Optional Cohort with dose to be determined, Japanese (4 active: 1 placebo) Placebo Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 9 Optional Cohort with dose to be determined, Chinese (4 active: 1 placebo) PF-07985631 Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 9 Optional Cohort with dose to be determined, Chinese (4 active: 1 placebo) Placebo Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 10 Optional Cohort with dose to be determined (6 active: 2 placebo) PF-07985631 Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 6 Dose F (6 active: 2 placebo) Placebo Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 7 Dose G (6 active: 2 placebo) PF-07985631 Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 10 Optional Cohort with dose to be determined (6 active: 2 placebo) Placebo Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 11 Optional Cohort with dose to be determined (6 active: 2 placebo) PF-07985631 Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC Cohort 11 Optional Cohort with dose to be determined (6 active: 2 placebo) Placebo Drug: PF-07985631 Experimental Pfizer compound which will be SC Drug: Placebo Placebo which will be SC
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months) Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months) Number of Participants With Notable Electrocardiogram (ECG) Values Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months) Number of Participants With Clinically Significant Abnormal Laboratory Parameters Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
- Secondary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) as data permit Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months) Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) as data permit Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months) Maximum Observed Plasma Concentration (Cmax) as data permit Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months) Time to Reach Maximum Observed Plasma Concentration (Tmax) as data permit Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months) Plasma Decay Half-Life (t1/2) as data permit Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)