A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension
NCT ID: NCT06137742
Last Updated: 2025-12-16
Study Results
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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RECRUITING
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2023-11-17
2027-02-13
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Part B is a 24-week, randomized, double blind, placebo-controlled study.
Study Groups
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PF-07868489
single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)
PF-07868489
Experimental Treatment
Placebo
single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)
Placebo for PF-07868489
Placebo
Interventions
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PF-07868489
Experimental Treatment
Placebo for PF-07868489
Placebo
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight \>50 kg.
* 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.
Exclusion Criteria
* smoking more than 10 cigarettes (or equivalent) per day or smoking history ≥10 pack-years.
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Anaheim Clinical Trials, LLC
Anaheim, California, United States
UCI Health - Costa Mesa
Costa Mesa, California, United States
UCI Health Center for Innovative Health Therapies (CIHT)
Orange, California, United States
University of California, Irvine Medical Center
Orange, California, United States
UC Davis Health Medical Center
Sacramento, California, United States
University of California Davis Health
Sacramento, California, United States
UCSF Health St. Mary's Hospital
San Francisco, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Norton Hospital
Louisville, Kentucky, United States
Norton Pulmonary Specialists
Louisville, Kentucky, United States
Icahn school of medicine at Mount Sinai
New York, New York, United States
Eastowne 100 Medical Office Building
Chapel Hill, North Carolina, United States
Eastowne Medical Office Building - Clinical Research Unit
Chapel Hill, North Carolina, United States
UNC Health - Eastowne Medical Office
Chapel Hill, North Carolina, United States
UNC Hospitals
Chapel Hill, North Carolina, United States
Investigational Drug Services Pharmacy
Morrisville, North Carolina, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Center for Advanced Lung Care
Providence, Rhode Island, United States
Medical University of South Carolina - Nexus
Charleston, South Carolina, United States
Medical University of South Carolina - Radiology
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Wesley Research Institute
Auchenflower, Queensland, Australia
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-capitale, Région de, Belgium
UZ Leuven
Leuven, Vlaams-brabant, Belgium
London Health Sciences Centre - Verspeeten Family Cancer Centre
London, Ontario, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Institut Klinicke a Experimentalni Mediciny
Prague, , Czechia
CHRU de Brest
Brest, Finistère, France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint Priest En Jarez, Pays de la Loire Region, France
Chu Grenoble Alpes
La Tronche, , France
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, Germany
Universitätsklinikum Regensburg
Regensburg, Bavaria, Germany
UKGM Gießen/Marburg
Giessen, Hesse, Germany
Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony, Germany
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí, Greece
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza E Brianza, Italy
ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Kobe University Hospital
Kobe, Hyōgo, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Yokohama City University Hospital
Kanagawa, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon], South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hammersmith Hospital
London, London, CITY of, United Kingdom
Golden Jubilee National Hospital
Clydebank, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2024-514064-17-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C5001001
Identifier Type: -
Identifier Source: org_study_id