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

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

NCT06137742•Pfizer

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Locations (67)

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

Key Dates

Start Date

November 17, 2023

Primary Completion Date

September 2, 2026

Completion Date

September 2, 2026

Last Updated

March 18, 2026

Enrollment

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

PF-07868489

DRUG

Placebo for PF-07868489

DRUG

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

NCT07218029

Pulmonary Arterial Hypertension

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RECRUITINGPHASE1/PHASE2

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

NCT06649110

Healthy Volunteers, Pulmonary Arterial Hypertension

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RECRUITINGPHASE1

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization