The primary objective of this study is to evaluate the safety and tolerability of single and multiple doses at escalating dose levels of mRNA-0184.
The study includes a SAD stage and MAD stage; the stages of SAD and MAD may overlap. The SAD stage will begin first, and data from this stage will inform decisions about dose levels in subsequent SAD cohorts and in the MAD stage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
Cardiology PC
Birmingham, Alabama, United States
University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama, United States
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 296
Serum Concentrations of mRNA Encoding Relaxin-2-variable Light Chain Kappa (Rel2- vlk mRNA)
Time frame: Day 1 (within 60 minutes predose) up to Day 183
Maximum Observed Plasma Concentration (Cmax) of Rel2-vlk mRNA
Time frame: Day 1 (within 60 minutes predose) up to Day 183
Area Under the Curve From Time 0 to Time t (AUC0-t) of Rel2-vlk mRNA
Time frame: Day 1 (within 60 minutes predose) up to Day 183
Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein
Time frame: Day 1 (within 60 minutes predose) up to Day 183
Maximum Observed Effect (Emax) of Rel2- vlk Protein
Time frame: Day 1 (within 60 minutes predose) up to Day 183
Area Under the Effect-Time Curve (AUEC) of Rel2-vlk Protein
Time frame: Day 1 (within 60 minutes predose) up to Day 183
Number of Participants With Anti-polyethylene glycol (PEG) Antibodies
Time frame: Baseline up to Day 183
Number of Participants With anti-Rel2-vlk Protein Antibodies
Time frame: Baseline up to Day 183
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Florida
Gainesville, Florida, United States
Jacksonville Center For Clinical Research - ERN - PPDS
Jacksonville, Florida, United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, United States
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Greater Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, Poland
Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slasiego Uniwersytetu Medycznego w Katowicach
Katowice, Silesian Voivodeship, Poland
Ninewells Hospital & Medical School
Dundee, Angus, United Kingdom
...and 4 more locations