A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
- Conditions
- Healthy
- Interventions
- Drug: PF-07985631Drug: Placebo
- Registration Number
- NCT06994897
- 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
* 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) or as an IV infusion in the arm (given directly into a vein) at the study clinic. Most participants will receive PF-07985631 or placebo one time. Some participants will receive PF-07985631 or placebo once a month for 3 months.
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 only 1 time will take part in this study for about 4 months. During this time, they will stay at the study clinic for 11 to 14 days and will have 8 more study visits at the study clinic.
Participants who take PF-07985631 or placebo more than once will take part in this study for about 6 months. During this time, they will stay at the study clinic for about 4 days a month 3 times and will have 8 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
- 84
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1: single ascending dose PF-07985631 Dose A (3 active: 2 placebo) Cohort 1: single ascending dose Placebo Dose A (3 active: 2 placebo) Cohort 2: single ascending dose PF-07985631 Dose B (3 active: 2 placebo) Cohort 2: single ascending dose Placebo Dose B (3 active: 2 placebo) Cohort 3: single ascending dose PF-07985631 Dose C (6 active: 2 placebo) Cohort 3: single ascending dose Placebo Dose C (6 active: 2 placebo) Cohort 4: single ascending dose PF-07985631 Dose D (6 active: 2 placebo) Cohort 4: single ascending dose Placebo Dose D (6 active: 2 placebo) Cohort 5: single ascending dose PF-07985631 Dose E (6 active: 2 placebo) Cohort 5: single ascending dose Placebo Dose E (6 active: 2 placebo) Cohort 6: single ascending dose PF-07985631 Dose F (6 active: 2 placebo) Cohort 6: single ascending dose Placebo Dose F (6 active: 2 placebo) Cohort 7: single ascending dose PF-07985631 Dose G (6 active: 2 placebo) Cohort 8: single dose PF-07985631 Optional Japanese Cohort dose to be determined (4 active: 2 placebo) Cohort 7: single ascending dose Placebo Dose G (6 active: 2 placebo) Cohort 8: single dose Placebo Optional Japanese Cohort dose to be determined (4 active: 2 placebo) Cohort 9: single dose PF-07985631 Optional Chinese Cohort dose to be determined (4 active: 2 placebo) Cohort 11 PF-07985631 Optional Cohort with dose to be determined (6 active: 2 placebo) Cohort 9: single dose Placebo Optional Chinese Cohort dose to be determined (4 active: 2 placebo) Cohort 11 Placebo Optional Cohort with dose to be determined (6 active: 2 placebo) Cohort 12 PF-07985631 Optional Cohort with dose to be determined (6 active: 2 placebo) Cohort 10: multiple dose PF-07985631 Dose to be determined, 3 doses planned (6 active: 2 placebo) Cohort 10: multiple dose Placebo Dose to be determined, 3 doses planned (6 active: 2 placebo) Cohort 12 Placebo Optional Cohort with dose to be determined (6 active: 2 placebo)
- 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 4.5 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 4.5 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 4.5 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 4.5 months)
- Secondary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): MD cohorts only Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months) Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): SAD cohorts only 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 Last Quantifiable Concentration (AUClast): SAD cohorts only Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months) Maximum Observed Plasma Concentration (Cmax) Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months) Time to Reach Maximum Observed Plasma Concentration (Tmax) Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months) Plasma Decay Half-Life (t1/2): SAD cohorts only Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)