Overview
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
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.