Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070, Belgium
Location status: Recruiting
NCT Number: NCT06994897
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) 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 may 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 10 more study visits at the study clinic.
During study clinic stays and study visits, blood samples will be done and safety reviews completed.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Phase 1
Brussels, Bruxelles-capitale, Région de, B-1070, Belgium
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Exclusion:
Experimental Pfizer compound which will be SC or IV
Placebo which will be SC or IV
Time frame: Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)
Time frame: Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)
Time frame: Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)
Time frame: Baseline (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)
Time frame: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)
Time frame: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
Time frame: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
Time frame: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)
Time frame: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 4.5 months)
Time frame: Predose (Day 1) up to 83 days after last dose of study drug (approximately up to 3 months)
Contact information is provided by the study sponsor or research team.
Pfizer
Industry
A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE DOSE-ESCALATION AND MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-07985631 IN HEALTHY ADULT PARTICIPANTS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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