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
Status: Recruiting
Location: See all (60) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• overtly healthy
• Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight \>50 kg.
• 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.
Locations
United States
California
Anaheim Clinical Trials, LLC
ACTIVE_NOT_RECRUITING
Anaheim
UCI Health - Costa Mesa
NOT_YET_RECRUITING
Costa Mesa
UCI Health Center for Innovative Health Therapies (CIHT)
NOT_YET_RECRUITING
Orange
University of California, Irvine Medical Center
NOT_YET_RECRUITING
Orange
UC Davis Health Medical Center
NOT_YET_RECRUITING
Sacramento
University of California Davis Health
NOT_YET_RECRUITING
Sacramento
UCSF Health St. Mary's Hospital
RECRUITING
San Francisco
UCSF Helen Diller Medical Center at Parnassus Heights
RECRUITING
San Francisco
Colorado
University of Colorado Anschutz Medical Campus
NOT_YET_RECRUITING
Aurora
Kentucky
Norton Hospital
NOT_YET_RECRUITING
Louisville
Norton Pulmonary Specialists
NOT_YET_RECRUITING
Louisville
North Carolina
Eastowne 100 Medical Office Building
RECRUITING
Chapel Hill
Eastowne Medical Office Building - Clinical Research Unit
RECRUITING
Chapel Hill
UNC Health - Eastowne Medical Office
RECRUITING
Chapel Hill
UNC Hospitals
RECRUITING
Chapel Hill
Investigational Drug Services Pharmacy
RECRUITING
Morrisville
New York
Icahn school of medicine at Mount Sinai
RECRUITING
New York
Rhode Island
Center for Advanced Lung Care
NOT_YET_RECRUITING
Providence
Rhode Island Hospital
NOT_YET_RECRUITING
Providence
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Medical University of South Carolina - Nexus
RECRUITING
Charleston
Medical University of South Carolina - Radiology
RECRUITING
Charleston
Other Locations
Australia
Wesley Research Institute
RECRUITING
Auchenflower
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Belgium
Université Libre de Bruxelles - Hôpital Erasme
RECRUITING
Brussels
UZ Leuven
RECRUITING
Leuven
Canada
London Health Sciences Centre - University Hospital
NOT_YET_RECRUITING
London
London Health Sciences Centre - Verspeeten Family Cancer Centre
NOT_YET_RECRUITING
London
China
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Zhongda Hospital Southeast University
RECRUITING
Nanjing
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
France
CHRU de Brest
RECRUITING
Brest
Chu Grenoble Alpes
NOT_YET_RECRUITING
La Tronche
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
RECRUITING
Saint Priest En Jarez
Germany
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
RECRUITING
Dresden
UKGM Gießen/Marburg
RECRUITING
Giessen
Universitätsmedizin Greifswald
RECRUITING
Greifswald
Thoraxklinik-Heidelberg gGmbH
RECRUITING
Heidelberg
Universitätsklinikum Regensburg
RECRUITING
Regensburg
Greece
University General Hospital ATTIKON - General Hospital of West Attica H AGIA VARVARA
NOT_YET_RECRUITING
Chaïdári
Italy
Fondazione IRCCS San Gerardo dei Tintori
NOT_YET_RECRUITING
Monza
ISMETT Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
NOT_YET_RECRUITING
Palermo
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Japan
Yokohama City University Hospital
NOT_YET_RECRUITING
Kanagawa
St. Marianna University Hospital
RECRUITING
Kawasaki
Kobe University Hospital
RECRUITING
Kobe
National Hospital Organization Okayama Medical Center
RECRUITING
Okayama
Tohoku University Hospital
RECRUITING
Sendai
Republic of Korea
Gachon University Gil Medical Center
RECRUITING
Namdong-gu
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Marqués de Valdecilla
NOT_YET_RECRUITING
Santander
United Kingdom
Golden Jubilee National Hospital
NOT_YET_RECRUITING
Clydebank
Hammersmith Hospital
RECRUITING
London
Royal Brompton Hospital
NOT_YET_RECRUITING
London
Royal Free Hospital
NOT_YET_RECRUITING
London
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2023-11-17
Estimated Completion Date: 2027-02-13
Participants
Target number of participants: 90
Treatments
Experimental: PF-07868489
single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)
Placebo_comparator: Placebo
single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)
Related Therapeutic Areas
Sponsors
Leads: Pfizer