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Active, Not Recruiting

NCT Number: NCT06965465

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

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 2-4 weeks until completing the study.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - Brussels

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-07999415

Biological

Participants will receive single doses of PF-07999415.

Placebo

Drug

Participants will receive matching placebo.

Primary outcomes

  1. Number of participants with treatment emergent adverse events.

    Time frame: First dose (Day 1) to up to final follow-up visit (Day 120)

Secondary outcomes

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

    Time frame: First dose (Day 1) to up to final follow-up visit (Day 120)

  2. Maximum observed concentration (Cmax) for PF-07999415

    Time frame: First dose (Day 1) to up to final follow-up visit (Day 120)

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

    Time frame: First dose (Day 1) to up to final follow-up visit (Day 120)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR-OPEN, PLACEBOCONTROLLED, SINGLE DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SUBCUTANEOUS ADMINISTRATION OF PF-07999415 IN HEALTHY ADULT PARTICIPANTS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 11, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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