臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 27, 2024
Last modified on	April. 09, 2026
Trial ID	jRCT2051240229

Scientific Title	A PHASE 1/2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ESCALATING DOSES OF PF-07868489 IN HEALTHY ADULT PARTICIPANTS AND, ADDITIONALLY, CLINICAL ACTIVITY OF REPEAT DOSES IN PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION
Public Title	A Study to Learn About the Study Medicine Called PF-07868489 in People With Pulmonary Arterial Hypertension

Contact for Scientific Queries	Name	Kawai Norisuke
	Affiliation	Pfizer R&D Japan G.K.
	Address	Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo
	Telephone	+81-3-5309-7000
	E-mail	clinical-trials@pfizer.com
Contact for Public Queries	Name	Clinical Trials Information Desk
	Affiliation	Pfizer R&D Japan G.K.
	Address	Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo
	Telephone	+81-3-5309-7000
	E-mail	clinical-trials@pfizer.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		April. 23, 2025
Actual date of first enrollment		April. 23, 2025
Target sample size		90
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	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.
	Exclusion 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.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pulmonary Arterial Hypertension
Intervention(s)		PF-07868489 Placebo
Primary Outcome(s)		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 Pulmonary Vascular Resistance (PVR) at Week24 [Time Frame: Baseline, Week 24]
Secondary Outcome(s)		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] N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) [Time Frame: Baseline, Week 24] 6MWD [Time Frame: Baseline, Week 24]

Primary Sponsor	Pfizer Japan Inc.

Secondary Sponsor

Name of Certified Review Board	Kobe University Hospital IRB
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Telephone	+81-78-382-6669
E-Mail	chiken@med.kobe-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 19, 2024

Plan to share IPD	No
Plan description	Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Plan to share IPD

Plan description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Secondary ID(s)	NCT06137742
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Australia/Belgium/China/Germany/Italy/Korea, Republic of/Spain/United Kingdom/United States/Canada/Czechia/France/Greece

History of Changes

No	Publication date
4	April. 09, 2026	(this page)	Changes
3	Dec. 17, 2025	Detail	Changes
2	Aug. 15, 2025	Detail	Changes
1	Dec. 27, 2024	Detail

List of change history