A Study to Learn How Different Amounts of the Study Medicine Called PF-07999415 Are Tolerated and Act in the Body in Healthy Adults

NCT06965465 | Active Not Recruiting Phase 1

• 2 other identifiers: C56710012024-520380-13-00
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called PF-07999415) in healthy adult participants. This study is seeking volunteers aged 18 to 65 years old who do not have any major health issues. Some participants in this study will receive a single dose of PF-07999415 as a shot in the thigh, abdomen, or arm at the study clinic. Afterward, participants will stay in a hospital-like setting for 2 weeks, where they will be monitored for reactions to the study medicine. The study team will compare the experiences of people receiving PF-07999415 to those of the people who do not. This will help the study team decide if PF-07999415 is safe. Participants will take part in this study for 3 to 7 months. During this time, participants will stay at the healthcare facility for 2 weeks and then come back for study visits every 2 weeks until completing the study.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment emergent adverse events.

  First dose (Day 1) to up to final follow-up visit (Day 85)

Secondary Outcomes (3)

• Area under the concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) for PF-07999415

  First dose (Day 1) to up to final follow-up visit (Day 85)

• Maximum observed concentration (Cmax) for PF-07999415

  First dose (Day 1) to up to final follow-up visit (Day 85)

• Time to maximum observed concentration (Tmax) for PF-07999415

  First dose (Day 1) to up to final follow-up visit (Day 85)

Study Arms (2)

PF-07999415

EXPERIMENTAL

Biological: PF-07999415

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PF-07999415 BIOLOGICAL

Participants will receive single doses of PF-07999415.

PF-07999415

Placebo DRUG

Participants will receive matching placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants of non-childbearing potential aged 18 to 65 years, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• Body Mass Index (BMI) of 18-33 kg/m2 and a total body weight \>50 kg (110 lb).

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, dermatological, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): August 22, 2026
• Study Completion (Estimated): August 22, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)