Pulmonary Arterial HypertensionPhase 1/2NCT06137742
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 study testing PF-07868489 in people with Pulmonary Arterial Hypertension, run by Pfizer at 46 sites in 12 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- PF-07868489
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 46 sitesin 12 countries
- Study dates
- 17 Nov 2023to 31 Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
46 sites in 12 countries.
46 sites in 12 countries
United States16 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Eastowne 100 Medical Office Building
Chapel Hill, North Carolina, 27514
Eastowne Medical Office Building - Clinical Research Unit
Chapel Hill, North Carolina, 27514
UNC Health - Eastowne Medical Office
Chapel Hill, North Carolina, 27514
UNC Hospitals
Chapel Hill, North Carolina, 27514
Medical University of South Carolina - Nexus
Charleston, South Carolina, 29425
Medical University of South Carolina - Radiology
Charleston, South Carolina, 29425
Medical University of South Carolina
Charleston, South Carolina, 29425
UCI Health - Costa Mesa
Costa Mesa, California, 92627
Investigational Drug Services Pharmacy
Morrisville, North Carolina, 27560
Icahn school of medicine at Mount Sinai
New York, New York, 10029
Mount Sinai Hospital
New York, New York, 10029
UCI Health Center for Innovative Health Therapies (CIHT)
Orange, California, 92868
University of California, Irvine Medical Center
Orange, California, 92868
UCSF Health St. Mary's Hospital
San Francisco, California, 94117
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143
Germany5 sites
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony, 01307
UKGM Gießen/Marburg
Giessen, Hesse, 35392
Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, 69126
Universitätsklinikum Regensburg
Regensburg, Bavaria, 93053
China4 sites
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Japan4 sites
St. Marianna University Hospital
Kawasaki, Kanagawa, 216-8511
Kobe University Hospital
Kobe, Hyōgo, 650-0017
National Hospital Organization Okayama Medical Center
Okayama, 701-1154
Tohoku University Hospital
Sendai, Miyagi, 980-8574
South Korea4 sites
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon], 21565
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351
Australia3 sites
Pulmonary Hypertension Research Queensland Pty Ltd
Auchenflower, Queensland, 4066
Wesley Research Institute
Auchenflower, Queensland, 4066
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
France3 sites
CHRU de Brest
Brest, Finistère, 29200
CHRU de Brest
Brest, Finistère, 29609
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint Priest En Jarez, Pays de la Loire Region, 42270
Belgium2 sites
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-capitale, Région de, 1070
UZ Leuven
Leuven, Vlaams-brabant, 3000
Spain2 sites
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de, 28046
Hospital Universitario 12 de Octubre
Madrid, 28041
United Kingdom1 site
Hammersmith Hospital
London, London, CITY of, W12 0HS
About this study
Official title: 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
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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- PF-07868489, Placebo for PF-07868489
- Keywords
- pulmonary, high lung artery pressure
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07868489Drug
Experimental Treatment
Placebo for PF-07868489Drug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PF-07868489 | Experimental | single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B) Receives: Drug: PF-07868489 |
| Placebo | Placebo comparator | single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B) Receives: Drug: Placebo for PF-07868489 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Part A
Measured: Baseline up to Day 113.
Number of Participants With Change From Baseline in Laboratory Tests Results
Part A
Measured: Baseline up to Day 113
Number of Participants With Vital Sign Abnormalities
Part A
Measured: Baseline up to Day 113
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
Part A
Measured: Baseline up to Day 113
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Part B
Measured: Baseline up to Day 253
Number of Participants With Change From Baseline in Laboratory Tests Results
Part B
Measured: Baseline up to Day 253
Number of Participants With Vital Sign Abnormalities
Part B
Measured: Baseline up to Day 253
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
Part B
Measured: Baseline up to Day 253
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week24
repeated doses
Measured: Baseline, Week 24
Secondary outcomes (11)
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
single dose
Measured: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
single dose
Measured: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Maximum Observed Plasma Concentration (Cmax)
single dose
Measured: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
single dose
Measured: 4-7 days
Incidence of Anti-Drug Antibody (ADA)
single dose
Measured: Baseline and up to week 16
Plasma Decay Half-Life (t1/2)
single dose
Measured: Day 113
Minimum Observed Plasma Trough Concentration (Cmin)
repeat doses
Measured: Day 253
Plasma Decay Half-Life (t1/2)
repeat doses
Measured: Day 253
Incidence of Anti-Drug Antibody (ADA)
repeated doses
Measured: Baseline and up to Day 253
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week24
repeated doses
Measured: Baseline, Week 24
6MWD
repeated doses
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start17 Nov 2023
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A is a sequential study. Part B is a parallel group study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137742
- Sponsor's protocol ID
- C5001001
- Other IDs
- 2024-514064-17-00
- Status last verified
- Aug 2026
- First submitted
- 14 Nov 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06137742
- Acronym / sponsor ID
- C5001001
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- pulmonary, high lung artery pressure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Part A is a sequential study. Part B is a parallel group study.
| Arm | Type | Receives |
|---|---|---|
| PF-07868489 | Experimental | Drug: PF-07868489single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B) |
| Placebo | Placebo comparator | Drug: Placebo for PF-07868489single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-07868489Experimental Treatment | Drug | PF-07868489 |
| Placebo for PF-07868489Placebo | Drug | Placebo |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 113.
Part A
Number of Participants With Change From Baseline in Laboratory Tests Results
Time frame: Baseline up to Day 113
Part A
Number of Participants With Vital Sign Abnormalities
Time frame: Baseline up to Day 113
Part A
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline up to Day 113
Part A
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 253
Part B
Number of Participants With Change From Baseline in Laboratory Tests Results
Time frame: Baseline up to Day 253
Part B
Number of Participants With Vital Sign Abnormalities
Time frame: Baseline up to Day 253
Part B
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline up to Day 253
Part B
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week24
Time frame: Baseline, Week 24
repeated doses
11 secondary outcomes
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
Time frame: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Time frame: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 4-7 days
Incidence of Anti-Drug Antibody (ADA)
Time frame: Baseline and up to week 16
Plasma Decay Half-Life (t1/2)
Time frame: Day 113
Minimum Observed Plasma Trough Concentration (Cmin)
Time frame: Day 253
Plasma Decay Half-Life (t1/2)
Time frame: Day 253
Incidence of Anti-Drug Antibody (ADA)
Time frame: Baseline and up to Day 253
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week24
Time frame: Baseline, Week 24
6MWD
Time frame: Baseline, Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
46 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PF-07868489 in people with Pulmonary Arterial Hypertension, run by Pfizer at 46 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Germany, China, Japan, South Korea and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to Day 113.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.