Phase
Condition
Williams Syndrome
Vascular Diseases
Stress
Treatment
PF-07868489
Placebo for PF-07868489
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria Part A:
overtly healthy
Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight >50 kg.
Key Exclusion Criteria Part A:
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.
Key Inclusion Criteria Part B:
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.
Key Exclusion Criteria Part B:
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.
Study Design
Connect with a study center
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510080
ChinaActive - Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan 410011
ChinaSite Not Available
Kobe University Hospital
Kobe, Hyogo 650-0017
JapanSite Not Available
St. Marianna University Hospital
Kawasaki, Kanagawa 216-8511
JapanSite Not Available
Tohoku University Hospital
Sendai, Miyagi 980-8574
JapanSite Not Available
Yokohama City University Hospital
Kanagawa, 236-0004
JapanSite Not Available
National Hospital Organization Okayama Medical Center
Okayama, 701-1154
JapanSite Not Available
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon] 21565
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul] 03080
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul] 03722
Korea, Republic ofSite Not Available
Hammersmith Hospital
London, London, CITY OF W12 0HS
United KingdomSite Not Available
Anaheim Clinical Trials, LLC
Anaheim, California 92801
United StatesSite Not Available
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesSite Not Available
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