This purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of DT-216P2 administered either subcutaneously (SC) and intravenously (IV) in normal healthy participants. Approximately 36 participants will be enrolled into this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Nucleus Network, Level 5, 89 Commercial Road
Melbourne, Victoria, Australia
Frequency of treatment emergent adverse events (TEAEs)
To evaluate the safety and tolerability of single ascending doses of DT-216P2 in normal healthy participants by frequency of treatment-emergent adverse events (TEAEs).
Time frame: From first dose to end of study, Day 30 post first dose administration.
Maximum Plasma Concentration (Cmax) of DT-216P2
Time frame: Pre-dose and up to 240 hours post first dose for both SC and IV infusion.
Time to Maximum Plasma Concentration (Tmax) of DT-216P2
Time frame: Pre-dose and up to 240 hours post first dose for both SC and IV infusion.
Area Under the Concentration-time Curve (AUC) of DT-216P2
Time frame: Pre-dose and up to 240 hours post first dose for both SC and IV infusion.
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