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 (27) 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 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.
Locations
United States
California
Anaheim Clinical Trials, LLC
ACTIVE_NOT_RECRUITING
Anaheim
UCSF Helen Diller Medical Center at Parnassus Heights
NOT_YET_RECRUITING
San Francisco
Colorado
University of Colorado Anschutz Medical Campus
NOT_YET_RECRUITING
Aurora
Rhode Island
Center for Advanced Lung Care
NOT_YET_RECRUITING
Providence
Rhode Island Hospital
NOT_YET_RECRUITING
Providence
Other Locations
Australia
Wesley Research Institute
NOT_YET_RECRUITING
Auchenflower
Belgium
Université Libre de Bruxelles - Hôpital Erasme
NOT_YET_RECRUITING
Brussels
China
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Shanghai Pulmonary Hospital
NOT_YET_RECRUITING
Shanghai
Germany
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
NOT_YET_RECRUITING
Dresden
UKGM Gießen/Marburg
NOT_YET_RECRUITING
Giessen
Thoraxklinik-Heidelberg gGmbH
NOT_YET_RECRUITING
Heidelberg
Italy
Fondazione IRCCS San Gerardo dei Tintori
NOT_YET_RECRUITING
Monza
Japan
Yokohama City University Hospital
NOT_YET_RECRUITING
Kanagawa
St. Marianna University Hospital
RECRUITING
Kawasaki
Kobe University Hospital
NOT_YET_RECRUITING
Kobe
National Hospital Organization Okayama Medical Center
RECRUITING
Okayama
Tohoku University Hospital
RECRUITING
Sendai
Republic of Korea
Gachon University Gil Medical Center
NOT_YET_RECRUITING
Namdong-gu
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Seoul
Spain
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
United Kingdom
Golden Jubilee National Hospital
NOT_YET_RECRUITING
Clydebank
Hammersmith 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)