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

NCT ID: NCT06965465

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-20

Study Completion Date

2026-06-04

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PF-07999415

Group Type EXPERIMENTAL

PF-07999415

Intervention Type BIOLOGICAL

Participants will receive single doses of PF-07999415.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive matching placebo.

Interventions

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PF-07999415

Participants will receive single doses of PF-07999415.

Intervention Type BIOLOGICAL

Placebo

Participants will receive matching placebo.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C5671001

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

Other Identifiers

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2024-520380-13-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

C5671001

Identifier Type: -

Identifier Source: org_study_id

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