New drug candidate targets Hard-to-Treat lung condition
NCT ID NCT06137742
First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This early-stage study by Pfizer tests a new drug called PF-07868489. First, it will be given to healthy volunteers to check safety and how the body processes it. Then, people with pulmonary arterial hypertension (PAH) will receive repeated doses over 24 weeks to see if it helps their condition. The main goal is safety, but researchers will also measure effects on blood pressure in the lungs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PF-07868489
- What this could lead to
- If it works, this could point toward a new treatment option for pulmonary arterial hypertension, a serious lung condition.
- What could go wrong
- This is a very early Phase 1/2 trial with only 97 participants. The drug may not prove safe or effective, and side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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97 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Jul 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
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CHRU de Brest
Brest, Finistère, 29200, France
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CHRU de Brest
Brest, Finistère, 29609, France
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Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint Priest En Jarez, Pays de la Loire Region, 42270, France
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Eastowne 100 Medical Office Building
Chapel Hill, North Carolina, 27514, United States
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Eastowne Medical Office Building - Clinical Research Unit
Chapel Hill, North Carolina, 27514, United States
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Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
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Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon], 21565, South Korea
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
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Hammersmith Hospital
London, London, CITY of, W12 0HS, United Kingdom
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Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
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Hospital Universitario La Paz
Madrid, Madrid, Comunidad de, 28046, Spain
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Icahn school of medicine at Mount Sinai
New York, New York, 10029, United States
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Investigational Drug Services Pharmacy
Morrisville, North Carolina, 27560, United States
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Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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Medical University of South Carolina - Nexus
Charleston, South Carolina, 29425, United States
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Medical University of South Carolina - Radiology
Charleston, South Carolina, 29425, United States
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Mount Sinai Hospital
New York, New York, 10029, United States
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National Hospital Organization Okayama Medical Center
Okayama, 701-1154, Japan
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Pulmonary Hypertension Research Queensland Pty Ltd
Auchenflower, Queensland, 4066, Australia
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Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
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Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea
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Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea
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Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
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St. Marianna University Hospital
Kawasaki, Kanagawa, 216-8511, Japan
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The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
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Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, 69126, Germany
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Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
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UCI Health - Costa Mesa
Costa Mesa, California, 92627, United States
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UCI Health Center for Innovative Health Therapies (CIHT)
Orange, California, 92868, United States
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UCSF Health St. Mary's Hospital
San Francisco, California, 94117, United States
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UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143, United States
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UKGM Gießen/Marburg
Giessen, Hesse, 35392, Germany
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UNC Health - Eastowne Medical Office
Chapel Hill, North Carolina, 27514, United States
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UNC Hospitals
Chapel Hill, North Carolina, 27514, United States
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UZ Leuven
Leuven, Vlaams-brabant, 3000, Belgium
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Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony, 01307, Germany
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University of California, Irvine Medical Center
Orange, California, 92868, United States
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Universitätsklinikum Regensburg
Regensburg, Bavaria, 93053, Germany
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Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475, Germany
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Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-capitale, Région de, 1070, Belgium
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Vseobecna fakultni nemocnice v Praze
Prague, 12808, Czechia
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Wesley Research Institute
Auchenflower, Queensland, 4066, Australia
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Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new drug keep pulmonary arterial hypertension in check over the long haul?
- Could light leg workouts revive Oxygen-Starved muscles in PAH?
- Texting therapy: could a simple phone message boost exercise and quality of life in a rare lung disease?