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

• Status: Recruiting
• Trial end date: 2026-09-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer

Criteria

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 32 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.