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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
Evaluation of Safety
Incidence of treatment emergent AEs
Time frame: Baseline through Study Completion (up to Day 14)
Evaluation of Safety
Change in laboratory safety assessments from baseline
Time frame: Baseline through Study Completion (up to Day 14)
Evaluation of Safety
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)
Evaluation of Safety
Number of participants with abnormal physical examination findings as assessed by the investigator
Time frame: Baseline through Study Completion (up to Day 14)
Area Under the Curve (AUC) will be assessed
Area under the plasma concentration versus time curve
Time frame: Multiple timepoints from Baseline through Study Completion (up to Day 14)
Maximum Blood Concentration (Cmax) will be assessed
Maximum observed concentration (Cmax)
Time frame: Multiple timepoints from Baseline through Study Completion (up to Day 14)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.