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COMPLETED
NCT04255875
PHASE1

Dose Escalation Study of PF-07209326 in Healthy Participants and Participants With Sickle Cell Disease

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

This Phase 1 first-in-human, first-in-patient, single ascending dose and multiple dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, and pharmacokinetics of PF-07209326 in healthy participants and participants with sickle cell disease.

Official title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED EVALUATION OF SINGLE DOSES OF PF-07209326 IN HEALTHY PARTICIPANTS (SAFETY, TOLERABILITY, AND PHARMACOKINETICS [PK]) FOLLOWED BY AN OPEN LABEL, REPEAT DOSE EVALUATION IN SICKLE CELL DISEASE PARTICIPANTS (SAFETY, TOLERABILITY, PK AND EFFICACY)

Key Details

Gender

All

Age Range

16 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2020-02-05

Completion Date

2023-07-07

Last Updated

2026-06-15

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Placebo

Participants will receive matching placebo

BIOLOGICAL

PF-07209326

Participants will receive SC or IV single ascending doses

BIOLOGICAL

PF-07209326

SCD participants will receive a multiple dose of subcutaneous PF-07209326

Locations (16)

New Haven Clinical Research Unit

New Haven, Connecticut, United States

Howard University College of Medicine

Washington D.C., District of Columbia, United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

Lee Health - Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

Foundation for Sickle Cell Disease Research

Hollywood, Florida, United States

Foundation for Sickle Cell Disease Research

Hollywood, Florida, United States

Children's Healthcare of Atlanta - Egleston Hospital-Aflac Cancer and Blood Disorders Center

Atlanta, Georgia, United States

University of Illinois at Chicago Clinical Research Center

Chicago, Illinois, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, United States

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, United States

CUIMC Research Pharmacy

New York, New York, United States

CUMC Research Pharmacy

New York, New York, United States

UT Physicians Comprehensive Sickle Cell Center Houston

Houston, Texas, United States

Memorial Hermann clinical research unit

Houston, Texas, United States

UT Physicians Comprehensive Sickle Cell Center Houston

Houston, Texas, United States