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

ID#: NCT06137742

Age: 18 - 65 years

Gender: All

Healthy Subjects: Accepts Healthy Volunteers

Study Phase: Phase 1/Phase 2

Recruitment Status: Recruiting

Start Date: November 17, 2023

End Date: February 13, 2027

Contact Information:
Pfizer CT.gov Call Center
1-800-718-1021
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: 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 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. 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.
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