There are 2 parts to this study: a single ascending dose (single dose of mRNA-6231) part and a multiple ascending dose (repeat doses of mRNA-6231) part. The main goal of this study is to evaluate the safety and tolerability of escalating doses of single and repeat subcutaneous (SC) administration of mRNA-6231. Dose levels of mRNA-6231 are planned to be investigated in a dose-escalation manner.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Sterile frozen liquid dispersion for injection
Nucleus Network Limited
Melbourne, Victoria, Australia
Number of Participants with Adverse Events (AEs) and Serious AEs
Time frame: Up to Day 84
Maximum Observed Concentration (Cmax) of mRNA (Serum) and SM-86 (Plasma)
Time frame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
Area Under the Concentration-Time Curve (AUC) of mRNA (Serum) and SM-86 (Plasma)
Time frame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
Time to Maximum to Observed Effect (TEmax) of mRNA-6231
Time frame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
Maximum Observed Effect (Emax) of mRNA-6231
Time frame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
Area Under the Effect Versus Time Curve (AUEClast) of mRNA-6231
Time frame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.