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

JRCT ID: jRCT2051240229

Registered date:27/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pulmonary Arterial Hypertension
• Date of first enrollment: 09/01/2025
• Target sample size: 90
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

*PF-07868489
*Placebo

Outcome(s)

Primary Outcome

*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 N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week24 [Time Frame: Baseline, Week 24]

Secondary Outcome

*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]
*PVR [Time Frame: Baseline, Week 24]
*6MWD [Time Frame: Baseline, Week 24]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

*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.

Exclude 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.

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT06137742