A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose (SAD/MAD) Study to Evaluate the Safety, Tolerability, PK, and Food Effect of GBT021601, a Hemoglobin S Polymerization Inhibitor, in Healthy Participants.

About the study

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.

Study point of contact

Eleanor Lisbon, MD, MPH
650-781-1765
[email protected]
Jessica Guider, MS, MPH, MBA
630-364-3275
[email protected]

Locations

1 United States site

1 Australia site

Age

18 to 55 Years

Phase

Phase 1

Study type

Interventional

Age

18 Years - 55 Years

Gender

All

Interventions

Drug

Compensation

Unknown

participation requirements

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

participation restrictions

– Positive pregnancy test or currently breastfeeding.

Locations

  • San Antonio, Texas, United States, ICON Early Phase Services, LLC, 78209 [Recruiting]
  • Nedlands, Western Australia, Australia, Linear Clinical Research, 6009 [Recruiting]

More info

View on ClinicalTrials.gov
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Last updated 2021-08-31