A Study to Evaluate GBT021601 in Single and Multiple Doses in Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Sickle Cell Disease

In brief

This first in human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and food effect of GBT021601, a hemoglobin S (HbS) polymerization inhibitor, in healthy participants.

Key facts

Study ID

NCT05036512

Run by

Pfizer

People needed

129

Starts

2020-12-09

Expected to finish

2023-02-07

Last updated by the study team

2023-07-25

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy males and females ≥ 18 to ≤ 55 years of age
• Body mass index ≥ 18.0 to ≤ 30.0 kg/m2
• Body weight ≥ 50 kg at screening and Day -1

You may not qualify if…

• Positive pregnancy test or currently breastfeeding.

Where it is running

• ICON Early Phase Services, LLC — San Antonio, Texas, United States
• Harry Perkins Institute of Medical Research — Nedlands, Western Australia, Australia
• Linear Clinical Research — Nedlands, Western Australia, Australia
• Oxford Compounding — North Perth, Western Australia, Australia

Full record on ClinicalTrials.gov

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