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Not yet recruiting NCT07235163

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

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PF-08065010, Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Baseline, approximately up to 5 months]
  • Number of Participants With Clinically Significant Laboratory Abnormalities [Time frame: Baseline, approximately up to 5 months]
  • Number of Participants With Vital Sign Abnormalities [Time frame: Baseline, approximately up to 5 months]
  • Number of Participants with Change from Baseline in Physical Exam (PE) Parameters [Time frame: Baseline, approximately up to 5 months]
  • Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters [Time frame: Baseline, approximately up to 5 months]
  • Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Baseline, approximately up to 7 months]
  • Number of Participants With Clinically Significant Laboratory Abnormalities [Time frame: Baseline, approximately up to 7 months]
  • Number of Participants with Vital Sign Abnormalities [Time frame: Baseline, approximately up to 7 months]
  • Number of Participants with Change from Baseline in Physical Exam (PE) Parameters [Time frame: Baseline, approximately up to 7 months]
  • Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters [Time frame: Baseline, approximately up to 7 months]
Secondary outcome measures (9)
  • Area Under the Plasma Concentration-time Profile from Time Zero to the Time of Last Quantifiable Concentration (AUClast) [Time frame: Predose (Day 1), approximately up to 5 months]
  • Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf) [Time frame: Predose (Day 1), approximately up to 5 months]
  • Maximum Observed Plasma Concentration (Cmax) [Time frame: Predose (Day 1), approximately up to 5 months]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [Time frame: 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. [Time frame: Predose (Day 1), approximately up to 5 months]
  • Area under the serum concentration time profile over the dosing interval of 28 days (AUCtau) [Time frame: Predose (Day 1), approximately up to 7 months]
  • Maximum Observed Plasma Concentration (Cmax) [Time frame: Predose (Day 1), approximately up to 7 months]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [Time frame: Predose (Day 1), approximately up to 7 months]
  • Plasma Decay Half-Life (t1/2) [Time frame: Predose (Day 1), approximately up to 7 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07235163 · C6341001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗