EI-001
DrugEI-001 IV infusion
NCT Number: NCT04994912
A First-in-Human, Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-001 in Healthy Volunteers.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Nucleus Network Pty Ltd, Melbourne, Victoria, Australia
To assess the safety and tolerability of single ascending intravenous (IV) doses of EI-001 in healthy volunteers
To assess the pharmacokinetics (PK) of single ascending IV doses of EI-001 in healthy volunteers
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EI-001 IV infusion
Placebo IV infusion
Time frame: Day 1
to assess blood pressure
Time frame: Day 1
to assess heart rate
Time frame: Day 1
to assess respiratory rate
Time frame: Day 1
To assess Maximum observed concentration (Cmax)
Time frame: Day 1
To assess time to maximum observed drug concentration (Tmax)
Time frame: Day 1
to assess AUC from time zero to the last measurable concentration (AUC0-t)
Elixiron Immunotherapeutics (Hong Kong) Ltd.
Industry
Title of Study: A First-in-Human, Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-001 in Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02206178
Healthy
Clermont-Ferrand, France
View Trial DetailsNCT07534020
Healthy
Addison, Illinois, United States
View Trial DetailsNCT07724015
Healthy
Jaén, Spain
View Trial DetailsNCT07404254
Beverage Intake, Caffeine
San Francisco, California, United States
View Trial Details