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

Last updated: May 4, 2026
Sponsor: Pfizer
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Pulmonary Arterial Hypertension

Stress

Williams Syndrome

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 40 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: 97
Treatment Group(s): 2
Primary Treatment: PF-07868489
Phase: 1/2
Study Start date:
November 17, 2023
Estimated Completion Date:
September 02, 2026

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown 2172563, New South Wales 2155400 2050
    Australia

    Site Not Available

  • Pulmonary Hypertension Research Queensland Pty Ltd

    Auchenflower, Queensland 4066
    Australia

    Site Not Available

  • Wesley Research Institute

    Auchenflower, Queensland 4066
    Australia

    Site Not Available

  • Wesley Research Institute

    Auchenflower 6943571, Queensland 2152274 4066
    Australia

    Site Not Available

  • Université Libre de Bruxelles - Hôpital Erasme

    Brussels, Bruxelles-capitale, Région DE 1070
    Belgium

    Site Not Available

  • Université Libre de Bruxelles - Hôpital Erasme

    Brussels 2800866, Bruxelles-capitale, Région de 1070
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, Vlaams-brabant 3000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven 2792482, Vlaams-brabant 3000
    Belgium

    Site Not Available

  • London Health Sciences Centre - University Hospital

    London, Ontario N6G 2M3
    Canada

    Site Not Available

  • London Health Sciences Centre - Verspeeten Family Cancer Centre

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • London Health Sciences Centre - University Hospital

    London 6058560, Ontario 6093943 N6G 2M3
    Canada

    Site Not Available

  • London Health Sciences Centre - Verspeeten Family Cancer Centre

    London 6058560, Ontario 6093943 N6A 5W9
    Canada

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou 1809858, Guangdong 1809935 510080
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha 1815577, Hunan 1806691 410011
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing 1799962, Jiangsu 1806260 210009
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality 200433
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200433
    China

    Site Not Available

  • Institut Klinicke a Experimentalni Mediciny

    Prague, 140 21
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808
    Czechia

    Site Not Available

  • Institut Klinicke a Experimentalni Mediciny

    Prague 3067696, 140 21
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Prague 3067696, 12808
    Czechia

    Site Not Available

  • CHRU de Brest

    Brest, Finistère 29200
    France

    Site Not Available

  • CHRU de Brest

    Brest 3030300, Finistère 29200
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord

    Saint Priest En Jarez, Pays de la Loire Region 42270
    France

    Site Not Available

  • Chu Grenoble Alpes

    La Tronche, 38700
    France

    Site Not Available

  • Chu Grenoble Alpes

    La Tronche 3006131, 38700
    France

    Site Not Available

  • Thoraxklinik-Heidelberg gGmbH

    Heidelberg, Baden-Wurttemberg 69126
    Germany

    Site Not Available

  • Thoraxklinik-Heidelberg gGmbH

    Heidelberg 2907911, Baden-Wurttemberg 2953481 69126
    Germany

    Site Not Available

  • Universitätsklinikum Regensburg

    Regensburg, Bavaria 93053
    Germany

    Site Not Available

  • Universitätsklinikum Regensburg

    Regensburg 2849483, Bavaria 2951839 93053
    Germany

    Site Not Available

  • UKGM Gießen/Marburg

    Giessen, Hesse 35392
    Germany

    Site Not Available

  • UKGM Gießen/Marburg

    Giessen 2920512, Hesse 2905330 35392
    Germany

    Site Not Available

  • UKGM Gießen/Marburg

    Gießen, Hessen 35392
    Germany

    Site Not Available

  • Universitätsmedizin Greifswald

    Greifswald, Mecklenburg-Vorpommern 17475
    Germany

    Site Not Available

  • Universitätsmedizin Greifswald

    Greifswald 2917788, Mecklenburg-Vorpommern 2872567 17475
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

    Dresden, Saxony 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

    Dresden 2935022, Saxony 2842566 01307
    Germany

    Site Not Available

  • Onassis Hospital

    Kallithea, Attica 17674
    Greece

    Site Not Available

  • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

    Chaïdári, Attikí 12462
    Greece

    Site Not Available

  • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

    Chaïdári 260183, Attikí 12462
    Greece

    Site Not Available

  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki, Central Macedonia 54636
    Greece

    Site Not Available

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Monza E Brianza 20900
    Italy

    Site Not Available

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza 3172629, Monza E Brianza 20900
    Italy

    Site Not Available

  • ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

    Palermo, 90127
    Italy

    Site Not Available

  • ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

    Palermo 2523920, 90127
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia 3171366, 27100
    Italy

    Site Not Available

  • Kobe University Hospital

    Kobe, Hyōgo 650-0017
    Japan

    Site Not Available

  • Kobe University Hospital

    Kobe 1859171, Hyōgo 1862047 650-0017
    Japan

    Site Not Available

  • St. Marianna University Hospital

    Kawasaki, Kanagawa 216-8511
    Japan

    Site Not Available

  • St. Marianna University Hospital

    Kawasaki 1859642, Kanagawa 1860291 216-8511
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai, Miyagi 980-8574
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai 2111149, Miyagi 2111888 980-8574
    Japan

    Site Not Available

  • Yokohama City University Hospital

    Kanagawa, 236-0004
    Japan

    Site Not Available

  • Yokohama City University Hospital

    Kanagawa 1860292, 236-0004
    Japan

    Site Not Available

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1154
    Japan

    Site Not Available

  • National Hospital Organization Okayama Medical Center

    Okayama 1854383, 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

  • Gachon University Gil Medical Center

    Namdong-gu, Incheon-gwangyeoksi [incheon] 21565
    South Korea

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul] 06351
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 03080
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul] 03722
    South Korea

    Site Not Available

  • Samsung Medical Center

    Seoul 1835848, Seoul-teukbyeolsi [seoul] 06351
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, Seoul-teukbyeolsi [seoul] 03080
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, Seoul-teukbyeolsi [seoul] 03722
    South Korea

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander 3109718, Cantabria 3336898 39008
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, Madrid, Comunidad de 28046
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid 3117735, Madrid, Comunidad de 28046
    Spain

    Site Not Available

  • Centro de Actividades Ambulatorias

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Hammersmith Hospital

    London, London, CITY of W12 0HS
    United Kingdom

    Site Not Available

  • Hammersmith Hospital

    London 2643743, London, CITY of W12 0HS
    United Kingdom

    Site Not Available

  • Golden Jubilee National Hospital

    Clydebank, G81 4DY
    United Kingdom

    Site Not Available

  • Golden Jubilee National Hospital

    Clydebank 2652730, G81 4DY
    United Kingdom

    Site Not Available

  • Royal Brompton Hospital

    London, SW3 6NP
    United Kingdom

    Site Not Available

  • Royal Free London NHS Foundation Trust, Royal Free Hospital

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Royal Brompton Hospital

    London 2643743, SW3 6NP
    United Kingdom

    Site Not Available

  • Royal Free Hospital

    London 2643743, NW3 2QC
    United Kingdom

    Site Not Available

  • Royal Free London NHS Foundation Trust, Royal Free Hospital

    London 2643743, NW3 2QG
    United Kingdom

    Site Not Available

  • Anaheim Clinical Trials, LLC

    Anaheim, California 92801
    United States

    Site Not Available

  • UCI Health - Costa Mesa

    Costa Mesa, California 92627
    United States

    Site Not Available

  • UCI Health Center for Innovative Health Therapies (CIHT)

    Orange, California 92868
    United States

    Site Not Available

  • University of California, Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • UC Davis Health Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California Davis Health

    Sacramento, California 95817
    United States

    Site Not Available

  • UCSF Health St. Mary's Hospital

    San Francisco, California 94117
    United States

    Site Not Available

  • UCSF Helen Diller Medical Center at Parnassus Heights

    San Francisco, California 94143
    United States

    Site Not Available

  • Anaheim Clinical Trials, LLC

    Anaheim 5323810, California 5332921 92801
    United States

    Site Not Available

  • UCI Health - Costa Mesa

    Costa Mesa 5339840, California 5332921 92627
    United States

    Site Not Available

  • UCI Health Center for Innovative Health Therapies (CIHT)

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • University of California, Irvine Medical Center

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • UC Davis Health Medical Center

    Sacramento 5389489, California 5332921 95817
    United States

    Site Not Available

  • University of California Davis Health

    Sacramento 5389489, California 5332921 95817
    United States

    Site Not Available

  • UCSF Health St. Mary's Hospital

    San Francisco 5391959, California 5332921 94117
    United States

    Site Not Available

  • UCSF Helen Diller Medical Center at Parnassus Heights

    San Francisco 5391959, California 5332921 94143
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Norton Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Norton Pulmonary Specialists

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Norton Hospital

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Site Not Available

  • Norton Pulmonary Specialists

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Site Not Available

  • Icahn school of medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • Icahn school of medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Eastowne 100 Medical Office Building

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Eastowne Medical Office Building - Clinical Research Unit

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • UNC Health - Eastowne Medical Office

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • UNC Hospitals

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Investigational Drug Services Pharmacy

    Morrisville, North Carolina 27560
    United States

    Site Not Available

  • Eastowne 100 Medical Office Building

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Site Not Available

  • Eastowne Medical Office Building - Clinical Research Unit

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Site Not Available

  • UNC Health - Eastowne Medical Office

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Site Not Available

  • UNC Hospitals

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Site Not Available

  • Investigational Drug Services Pharmacy

    Morrisville 4480285, North Carolina 4482348 27560
    United States

    Site Not Available

  • Center for Advanced Lung Care

    Providence, Rhode Island 02904
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Center for Advanced Lung Care

    Providence 5224151, Rhode Island 5224323 02904
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina - Nexus

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina - Radiology

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Medical University of South Carolina - Nexus

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Medical University of South Carolina - Radiology

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Medical University of South Carolina-Nexus

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

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