NCT06137742CompletedPhase 1/2
A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension
A PHASE 1 / 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ESCALATING DOSES OF PF-07868489 IN HEALTHY ADULT PARTICIPANTS AND, ADDITIONALLY, CLINICAL ACTIVITY OF REPEAT DOSES IN PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 97 (actual)
- First submitted
- 14 Nov 2023
- Start date
- 17 Nov 2023
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Pfizer
- NCT number
- NCT06137742
- EU CT number
- 2024-514064-17-00
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 97
- From 17 Nov 2023 to the primary completion date, 31 Jul 2026
- 53 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Stopped receiving pulmonary hypertension chronic general supportive therapy 90 days prior to Day 1.
- 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.
Other illness
- clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, infections or allergic disease.
- Pulmonary capillary wedge pressure \> 15 mmHg on right heart catheterization (RHC) conducted during Screening.
Lab values
- Any medical or psychiatric condition or laboratory abnormality.
Other
- smoking more than 10 cigarettes (or equivalent) per day or smoking history ≥10 pack-years.
- Participants who smoke more than 10 cigarettes (or equivalent) per day or has a smoking history ≥10 pack-years.
Who the study is looking for
- overtly healthy
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (53)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wesley Research Institute Coordinator of this site? Confirm its status | Auchenflower | Australia | Unknown status |
| Pulmonary Hypertension Research Queensland Pty Ltd Coordinator of this site? Confirm its status | Auchenflower | Australia | Unknown status |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhongda Hospital Southeast University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Institute for Clinical and Experimental Medicine Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Universitaetsklinikum Giessen und Marburg GmbH Coordinator of this site? Confirm its status | Giessen | Germany | Completed |
| Universitaetsmedizin Greifswald KöR Coordinator of this site? Confirm its status | Greifswald | Germany | Completed |
| Thoraxklinik Heidelberg gGmbH Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| Universitaetsklinikum Regensburg AöR Coordinator of this site? Confirm its status | Regensburg | Germany | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Completed |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Completed |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Completed |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Completed |
| Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Coordinator of this site? Confirm its status | Chaïdári | Greece | Completed |
| Onassis Cardiac Surgery Center Coordinator of this site? Confirm its status | Kallithea | Greece | Completed |
| University General Hospital of Thessaloniki - AHEPA Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Completed |
| Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.l. Coordinator of this site? Confirm its status | Palermo | Italy | Completed |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Completed |
| St. Marianna University Hospital Coordinator of this site? Confirm its status | Kawasaki | Japan | Unknown status |
| Kobe University Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| National Hospital Organization Okayama Medical Center Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Namdong-gu | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Anaheim Clinical Trials, LLC Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Eastowne 100 Medical Office Building Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| UNC Hospitals Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| UNC Health - Eastowne Medical Office Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Eastowne Medical Office Building - Clinical Research Unit Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Medical University of South Carolina - Nexus Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Medical University of South Carolina - Radiology Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| UCI Health - Costa Mesa Coordinator of this site? Confirm its status | Costa Mesa | United States | Unknown status |
| Investigational Drug Services Pharmacy Coordinator of this site? Confirm its status | Morrisville | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| UCI Health Center for Innovative Health Therapies (CIHT) Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| University of California Irvine Medical Center Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| UCSF Health St. Mary's Hospital Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| UCSF Helen Diller Medical Center at Parnassus Heights Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.