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

NCT06137742 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: C50010012024-514064-17-00
• Study Type: interventional
• Target: 97
• Locations: 14 countries
• Sites: 68

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Keywords

pulmonary; high lung artery pressure

Outcome Measures

Primary Outcomes (9)

• Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Part A

  Baseline up to Day 113.

• Number of Participants With Change From Baseline in Laboratory Tests Results

  Part A

  Baseline up to Day 113

• Number of Participants With Vital Sign Abnormalities

  Part A

  Baseline up to Day 113

• Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters

  Part A

  Baseline up to Day 113

• Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Part B

  Baseline up to Day 253

• Number of Participants With Change From Baseline in Laboratory Tests Results

  Part B

  Baseline up to Day 253

• Number of Participants With Vital Sign Abnormalities

  Part B

  Baseline up to Day 253

• Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters

  Part B

  Baseline up to Day 253

• Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week24

  repeated doses

  Baseline, Week 24

Secondary Outcomes (11)

• Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)

  Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

  Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose

• Maximum Observed Plasma Concentration (Cmax)

  Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  4-7 days

• Incidence of Anti-Drug Antibody (ADA)

  Baseline and up to week 16

Study Arms (2)

PF-07868489

EXPERIMENTAL

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

Drug: PF-07868489

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo for PF-07868489

Interventions

PF-07868489 DRUG

Experimental Treatment

PF-07868489

Placebo for PF-07868489 DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• overtly healthy
• Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight \>50 kg.

You may not qualify if:

• 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.
• 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.
• MWD ≥ 150 and ≤ 450.
• Pre-randomization RHC documenting a minimum of PVR ≥ 400 dyn ∙sec/cm5.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (68)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

UCI Health - Costa Mesa

Costa Mesa, California, 92627, United States

Location

UCI Health Center for Innovative Health Therapies (CIHT)

Orange, California, 92868, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

UC Davis Health Medical Center

Sacramento, California, 95817, United States

Location

University of California Davis Health

Sacramento, California, 95817, United States

Location

UCSF Health St. Mary's Hospital

San Francisco, California, 94117, United States

Location

UCSF Helen Diller Medical Center at Parnassus Heights

San Francisco, California, 94143, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Norton Hospital

Louisville, Kentucky, 40202, United States

Location

Norton Pulmonary Specialists

Louisville, Kentucky, 40202, United States

Location

Icahn school of medicine at Mount Sinai

New York, New York, 10029, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Eastowne 100 Medical Office Building

Chapel Hill, North Carolina, 27514, United States

Location

Eastowne Medical Office Building - Clinical Research Unit

Chapel Hill, North Carolina, 27514, United States

Location

UNC Health - Eastowne Medical Office

Chapel Hill, North Carolina, 27514, United States

Location

UNC Hospitals

Chapel Hill, North Carolina, 27514, United States

Location

Investigational Drug Services Pharmacy

Morrisville, North Carolina, 27560, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Center for Advanced Lung Care

Providence, Rhode Island, 02904, United States

Location

Medical University of South Carolina - Nexus

Charleston, South Carolina, 29425, United States

Location

Medical University of South Carolina - Radiology

Charleston, South Carolina, 29425, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Pulmonary Hypertension Research Queensland Pty Ltd

Auchenflower, Queensland, 4066, Australia

Location

Wesley Research Institute

Auchenflower, Queensland, 4066, Australia

Location

Université Libre de Bruxelles - Hôpital Erasme

Brussels, Bruxelles-capitale, Région de, 1070, Belgium

Location

UZ Leuven

Leuven, Vlaams-brabant, 3000, Belgium

Location

University Of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

London Health Sciences Centre - Verspeeten Family Cancer Centre

London, Ontario, N6A 5W9, Canada

Location

London Health Sciences Centre - University Hospital

London, Ontario, N6G 2M3, Canada

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Vseobecna fakultni nemocnice v Praze

Prague, 12808, Czechia

Location

Institut Klinicke a Experimentalni Mediciny

Prague, 140 21, Czechia

Location

CHRU de Brest

Brest, Finistère, 29200, France

Location

CHRU de Brest

Brest, Finistère, 29609, France

Location

Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord

Saint Priest En Jarez, Pays de la Loire Region, 42270, France

Location

Chu Grenoble Alpes

La Tronche, 38700, France

Location

Thoraxklinik-Heidelberg gGmbH

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Universitätsklinikum Regensburg

Regensburg, Bavaria, 93053, Germany

Location

UKGM Gießen/Marburg

Giessen, Hesse, 35392, Germany

Location

Universitätsmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

Dresden, Saxony, 01307, Germany

Location

Onassis Hospital

Kallithea, Attica, 17674, Greece

Location

University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

Chaïdári, Attikí, 12462, Greece

Location

AHEPA University General Hospital of Thessaloniki

Thessaloniki, Central Macedonia, 54636, Greece

Location

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza, 20900, Italy

Location

ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

Palermo, 90127, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

St. Marianna University Hospital

Kawasaki, Kanagawa, 216-8511, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Yokohama City University Hospital

Kanagawa, 236-0004, Japan

Location

National Hospital Organization Okayama Medical Center

Okayama, 701-1154, Japan

Location

Gachon University Gil Medical Center

Namdong-gu, Incheon-gwangyeoksi [incheon], 21565, South Korea

Location

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea

Location

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de, 28046, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hammersmith Hospital

London, London, CITY of, W12 0HS, United Kingdom

Location

Golden Jubilee National Hospital

Clydebank, G81 4DY, United Kingdom

Location

Royal Free London NHS Foundation Trust, Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A is an investigator- and participant-blind, sponsor-open, placebo-controlled, single ascending dose. Part B is a 24-week, randomized, double blind, placebo-controlled study.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A is a sequential study. Part B is a parallel group study.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: November 17, 2023
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): September 2, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (4); KR (4); AU (3); FR (4); US (23); DE (5); JP (5); GR (3); CA (3); CZ (2); IT (3); GB (4); BE (2); ES (3)