Testing how a new medicine is tolerated in healthy adults
A PHASE 1, RANDOMIZED STUDY WITH DOUBLE-BLIND AND SPONSOR-OPEN, PLACEBO-CONTROLLED SINGLE- AND MULTIPLE-DOSE ESCALATION TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-08049820 IN HEALTHY ADULT PARTICIPANTS
This study is testing a new medicine to see how well healthy adults can tolerate it and if food affects how their bodies absorb it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06686797 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and tolerability of a new medication called PF-08049820 in healthy adults. It will investigate how the body processes this medication and whether food influences its absorption in the bloodstream. Participants will be divided into groups and receive either the study medication or a placebo during multiple dosing periods. The study specifically seeks healthy individuals aged 18 to 65 with a certain body mass index and weight criteria, including a subgroup of participants with Japanese ancestry.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18 to 65 who meet specific BMI and weight criteria, with some participants required to have Japanese ancestry.
Not a fit: Patients with significant medical conditions or those with a history of certain infections or substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of PF-08049820's safety profile, paving the way for its use in treating moderate to severe atopic dermatitis.
How similar studies have performed: While this study focuses on a specific medication, similar studies evaluating the safety of new treatments in healthy populations have shown success in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy males and females who can no longer have children. 2. Body mass index (BMI) of 16-32 kg/m2; and a total body weight \>50kg (110 lb.). Japanese participants only: a total body weight \>45 kg is acceptable. Cohort 3 only: 3. Have 4 biological Japanese grandparents who were born in Japan Exclusion criteria 1. Evidence or history of clinically significant medical conditions. 2. 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). 3. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. 4. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Where this trial is running
New Haven, Connecticut
- Pfizer Clinical Research Unit - New Haven — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.