This will be a single centre, Phase 1, Placebo-controlled, Randomized, Doubleblind, SAD \& MAD Study to Assess the Safety, Tolerability and PK of HM201 in Healthy Subjects.
Objective of the study is to assess the safety, tolerability, and PK of single and multiple intravenous administration of HM201. The study design consists of a SAD study of 4 cohorts, 8 subjects each cohort and a different dose level per cohort. In each cohort 2 will receive the placebo while rest of group will be administered with HM201. A total of 32 subjects are planned for the SAD study. MAD part will begin after cohort 1 and 2 of SAD is completed. MAD will consist of 8 subjects; 2 will receive the placebo while 6 will be administered with HM201. MAD will be conducted in a dose escalation manner with 4 weekly doses administered to all subjects. One randomization scheme will be produced for each cohort separately.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
53
Nucleus Network Pty Ltd
Herston, Queensland, Australia
Number and percentage of treatment-emergent adverse event, serious adverse event and discontinuation.
Time frame: Up to 15 days post last infusion for both SAD & MAD
Plasma concentrations of HM201
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 1
Area under the plasma concentration versus time curve (AUC)
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 2
Peak Plasma Concentration (Cmax)
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 3
Time of peak plasma concentration (Tmax)
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 4
Concentration at the last planned timepoint prior to dosing (Ctrough)
Time frame: MAD: Up to Day 36
Pharmacokinetic assessment 5
Mean residence time (MRT)
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 6
Drug clearance (CL) \& Clearance at steady state (CLss)
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 7
Volume of distribution at steady state (Vss) \& during terminal phase (VZ)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo will be administered intravenously.
Time frame: SAD: Up to Day 15. MAD: Up to Day 36
Pharmacokinetic assessment 8
Half life (T1/2)
Time frame: SAD: Up to Day 15. MAD: Up to Day 36