NCT04255875

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Part 1 will evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of PF-07209326 delivered by subcutaneous injection or intravenous delivery in healthy volunteer participants. After establishing the safety and tolerability in healthy participants, Part 2 will evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of subcutaneously delivered multiple dose of PF-07209326 in participants with sickle cell disease.

Conditions

• Healthy
• Sickle Cell Anemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-02-05
• Primary completion: 2023-07-07
• Completion: 2023-07-07
• First posted: 2020-02-05
• Last updated: 2023-12-18

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study