A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension

Last updated: April 16, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

1/2

Condition

Williams Syndrome

Vascular Diseases

Stress

Treatment

PF-07868489

Placebo for PF-07868489

Clinical Study ID

NCT06137742
C5001001
2024-514064-17-00
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of the study is to learn how the study medicine called PF-07868489 is tolerated and acts in healthy adult people and people with pulmonary arterial hypertension (PAH).

Part A:

An investigator- and participant-blind, sponsor-open, placebo-controlled, single ascending dose study to assess the safety, tolerability, and pharmacokinetics (PK) of PF-07868489 in healthy adult participants.

Part B:

A 24-week, randomized, double blind, placebo-controlled study to assess the safety, tolerability, PK, and pharmacodynamics (PD) of PF-07868489 in adult participants with PAH.

Eligibility Criteria

Inclusion

Key Inclusion Criteria Part A:

  • overtly healthy

  • Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight >50 kg.

Key Exclusion Criteria Part A:

  • clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, infections or allergic disease.

  • smoking more than 10 cigarettes (or equivalent) per day or smoking history ≥10 pack-years.

Key Inclusion Criteria Part B:

  • diagnosis of pulmonary arterial hypertension (PAH)

  • stable dose of standard of care PAH vasodilators

  • BMI 16 to 32 kg/m2; and a total body weight >45 kg.

  • 6MWD ≥ 150 and ≤ 450.

  • Pre-randomization RHC documenting a minimum of PVR ≥ 400 dyn ∙sec/cm5.

Key Exclusion Criteria Part B:

  • Any medical or psychiatric condition or laboratory abnormality.

  • Stopped receiving pulmonary hypertension chronic general supportive therapy 90 days prior to Day 1.

  • Pulmonary capillary wedge pressure > 15 mmHg on right heart catheterization (RHC) conducted during Screening.

  • History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product.

  • Major surgery within 8 weeks prior to randomization.

  • Participants who smoke more than 10 cigarettes (or equivalent) per day or has a smoking history ≥10 pack-years.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: PF-07868489
Phase: 1/2
Study Start date:
November 17, 2023
Estimated Completion Date:
February 13, 2027

Connect with a study center

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • Kobe University Hospital

    Kobe, Hyogo 650-0017
    Japan

    Site Not Available

  • St. Marianna University Hospital

    Kawasaki, Kanagawa 216-8511
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai, Miyagi 980-8574
    Japan

    Site Not Available

  • Yokohama City University Hospital

    Kanagawa, 236-0004
    Japan

    Site Not Available

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1154
    Japan

    Site Not Available

  • Gachon University Gil Medical Center

    Namdong-gu, Incheon-gwangyeoksi [incheon] 21565
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul] 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul] 03722
    Korea, Republic of

    Site Not Available

  • Hammersmith Hospital

    London, London, CITY OF W12 0HS
    United Kingdom

    Site Not Available

  • Anaheim Clinical Trials, LLC

    Anaheim, California 92801
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

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