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

NCT04255875 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-12-18

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2023-07-07
Completion
2023-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04255875 on ClinicalTrials.gov