Nucleus Network Pty Ltd
Melbourne, Victoria, 3004, Australia
NCT Number: NCT06536101
This study is for the evaluation of the safety, tolerability, PK, PD, and biomarker activity of GIM-407 in healthy volunteers in the absence of any disease-related or potentially confounding factors.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Melbourne, Victoria, 3004, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
GIM-407 oral dose
Matching placebo oral dose
Time frame: Baseline through Study Completion (up to Day 14)
Incidence of treatment emergent AEs
Time frame: Baseline through Study Completion (up to Day 14)
Change in laboratory safety assessments from baseline
Time frame: Baseline through Study Completion (up to Day 14)
Number of participants with clinically significant abnormal 12-lead ECG results as assessed by the investigator
Time frame: Baseline through Study Completion (up to Day 14)
Number of participants with abnormal physical examination findings as assessed by the investigator
Time frame: Multiple timepoints from Baseline through Study Completion (up to Day 14)
Area under the plasma concentration versus time curve
Time frame: Multiple timepoints from Baseline through Study Completion (up to Day 14)
Maximum observed concentration (Cmax)
Georgiamune Inc
Industry
A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GIM-407 in Healthy Adult Participants
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.
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