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

Pfizer

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Placebo for PF-07868489; Drug: PF-07868489

Study type: Interventional

Funder types: Industry

Identifiers

NCT06137742

C5001001

2024-514064-17-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

PF-07868489

Experimental group

Description:

single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)

Treatment:

Drug: PF-07868489

Placebo

Placebo Comparator group

Description:

single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)

Treatment:

Drug: Placebo for PF-07868489