A Study to Learn How Different Amounts of the Study Medicine Called PF-08065010 Are Tolerated and Act in the Body of Healthy Adults

Официальное название

AN INTERVENTIONAL, PHASE 1, RANDOMIZED STUDY WITH DOUBLE-BLIND AND SPONSOR-OPEN, PLACEBO-CONTROLLED SINGLE AND MULTIPLE DOSE ESCALATION TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF PF-08065010 IN HEALTHY ADULT PARTICIPANTS

Обзор

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.

Вмешательства

• Препарат PF-08065010
  Experimental Pfizer compound which will be subcutaneous (SC) or intravenous (IV).
• Препарат Placebo
  Placebo which will be SC or IV

Первичные конечные точки

• Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Baseline, approximately up to 5 months]
• Number of Participants With Clinically Significant Laboratory Abnormalities [Срок оценки: Baseline, approximately up to 5 months]
• Number of Participants With Vital Sign Abnormalities [Срок оценки: Baseline, approximately up to 5 months]
• Number of Participants with Change from Baseline in Physical Exam (PE) Parameters [Срок оценки: Baseline, approximately up to 5 months]
• Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters [Срок оценки: Baseline, approximately up to 5 months]
• Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Baseline, approximately up to 7 months]
• Number of Participants With Clinically Significant Laboratory Abnormalities [Срок оценки: Baseline, approximately up to 7 months]
• Number of Participants with Vital Sign Abnormalities [Срок оценки: Baseline, approximately up to 7 months]
• Number of Participants with Change from Baseline in Physical Exam (PE) Parameters [Срок оценки: Baseline, approximately up to 7 months]
• Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters [Срок оценки: Baseline, approximately up to 7 months]

Вторичные конечные точки (9)

• Area Under the Plasma Concentration-time Profile from Time Zero to the Time of Last Quantifiable Concentration (AUClast) [Срок оценки: Predose (Day 1), approximately up to 5 months]
• Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf) [Срок оценки: Predose (Day 1), approximately up to 5 months]
• Maximum Observed Plasma Concentration (Cmax) [Срок оценки: Predose (Day 1), approximately up to 5 months]
• Time to Reach Maximum Observed Plasma Concentration (Tmax) [Срок оценки: Predose (Day 1), approximately up to 5 months]
• Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. [Срок оценки: Predose (Day 1), approximately up to 5 months]
• Area under the serum concentration time profile over the dosing interval of 28 days (AUCtau) [Срок оценки: Predose (Day 1), approximately up to 7 months]
• Maximum Observed Plasma Concentration (Cmax) [Срок оценки: Predose (Day 1), approximately up to 7 months]
• Time to Reach Maximum Observed Plasma Concentration (Tmax) [Срок оценки: Predose (Day 1), approximately up to 7 months]
• Plasma Decay Half-Life (t1/2) [Срок оценки: Predose (Day 1), approximately up to 7 months]

Критерии участия

Критерии включения

• male or female between 18 and 65 years of age
• deemed to be healthy

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07235163 · C6341001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗