A Study to Learn About the Study Medicine Called PF-07868489 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051240229

Enrollment

Registered

2024-12-27

Start date

2025-04-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

*PF-07868489 *Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *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 = 400 dyn *sec/cm5.

Exclusion criteria

Exclusion criteria: *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.

Design outcomes

Primary

Measure	Time frame
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to Day 253] Number of Participants With Change From Baseline in Laboratory Tests Results [Time Frame: Baseline up to Day 253] Number of Participants With Vital Sign Abnormalities [Time Frame: Baseline up to Day 253] Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters [Time Frame: Baseline up to Day 253] *Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week24 [Time Frame: Baseline, Week 24]	—

Measure

Time frame

*Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to Day 253] *Number of Participants With Change From Baseline in Laboratory Tests Results [Time Frame: Baseline up to Day 253] *Number of Participants With Vital Sign Abnormalities [Time Frame: Baseline up to Day 253] *Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters [Time Frame: Baseline up to Day 253] *Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week24 [Time Frame: Baseline, Week 24]

—

Secondary

Measure	Time frame
Minimum Observed Plasma Trough Concentration (Cmin) and Decay Half-Life (t1/2) [Time Frame: Day 253] Incidence of Anti-Drug Antibody (ADA) [Time Frame: Baseline and up to Day 253] N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) [Time Frame: Baseline, Week 24] 6MWD [Time Frame: Baseline, Week 24]	—

Countries

Australia, Belgium, Canada, China, Czechia, France, Germany, Greece, Italy, Japan, Korea, Republic of, Spain, United Kingdom, United States

Contacts

Public ContactClinical Trials Information Desk

Pfizer R&D Japan G.K.

clinical-trials@pfizer.com+81-3-5309-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026