This is a Phase 1, FIH, single-center, randomized, placebo controlled, dose escalation study to evaluate the safety, tolerability, PK, and PD of mRNA-1944 in healthy adult subjects. Cohorts of mRNA-1944 are planned to be investigated in a sequential dose escalation manner.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
39
PPD Phase 1 Clinical Research Unit
Austin, Texas, United States
Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities
Time frame: Through 13 months of study participation
Area under the concentration versus time curve (AUC)
Time frame: Baseline through 28 days post dose
Maximum observed serum concentration (Cmax) after administration of mRNA-1944
Time frame: Baseline through 28 days post dose
Time of Cmax (tmax)
Time frame: Baseline through 28 days post dose
Terminal elimination half-life (t1/2)
Time frame: Baseline through 28 days post dose
Maximum observed effect (Emax) for chikungunya virus IgG
Time frame: Baseline through 13 months
Time to maximum observed effect for (TEmax) for chikungunya virus IgG
Time frame: Baseline through 13 months
Area under the effect curve (AUEC) for chikungunya virus IgG
Time frame: Baseline through 13 months
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