Testing the safety and effects of PF-07314470 in healthy adults
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE AND MULTIPLE SUBCUTANEOUS DOSES OF PF-07314470 IN HEALTHY PARTICIPANTS
This study is testing a new medication called PF-07314470 in healthy adults to see how safe it is and how the body handles it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 103 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06821750 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and pharmacokinetics of a medication called PF-07314470 in healthy adult participants. The study will involve administering varying doses of the medication and a placebo to assess how well the body tolerates it and how it is processed. Participants will be closely monitored for any adverse effects and to gather data on the drug's absorption and elimination. The trial is designed to provide foundational information for future studies involving this medication.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males aged 18 to 45 and healthy females aged 18 to 55 with a specific BMI range.
Not a fit: Patients with significant medical or psychiatric conditions, or those who use tobacco or prohibited medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help establish the safety profile of PF-07314470, paving the way for its use in treating various conditions.
How similar studies have performed: Other studies assessing the safety of new medications in healthy volunteers have shown success, making this approach a standard practice in drug development.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Healthy males aged 18 to 45 years and healthy females aged 18 to 55 years * Body Mass Index (BMI) of 16-32 kg/m2, and a total body weight greater than 50 kg (110 lb); for Japanese participants only, a total body weight greater than 45 kg * for Japanese participants only, enrolling as Japanese must have 4 biological grandparents who were born in Japan. Key Exclusion Criteria: * Evidence or history of clinically significant medical or psychiatric conditions * Prior or current use of any prohibited medications * History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening * Pregnant or breastfeeding females, males with partners currently pregnant, or males or females pursuing artificial reproductive technologies * Use of tobacco/nicotine containing products
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.