A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RT-114 in Healthy Volunteers
The goal of this Phase 1 study is to evaluate the safety and tolerability of RT-114 in healthy volunteers. The main objectives are: Primary: To evaluate safety and tolerability of RT-114 when administered as single and multiple doses by assessing treatment emergent adverse events (TEAEs) in healthy volunteers Secondary: * To determine the pharmacokinetics of RT-114 administered as single and multiple doses * To determine the pharmacodynamic effects of RT-114 administered as multiple doses In the single dose portion of the study participants will either receive the drug via a subcutaneous injection or an oral pill (RT-114). In the repeat dose portion of the study participants will randomized to either RT-114 or a placebo.
• Participant is ambulatory and between 18 to 65 years of age
• Body mass index between:
‣ Part A: 19 - 32 kg/m2
⁃ Part B: \>30 kg/m2
• Female volunteers must be non-pregnant or non-lactating during study participation
• Male volunteers must agree to use acceptable forms of contraception, if necessary, and to not donate sperm during study participation
• Have suitable venous access for blood sampling
• In good general health confirmed by medical history, physical examination, and absence of clinically important laboratory abnormalities per Investigator's judgment
• Participant understands the nature of the study, is willing to comply with protocol defined evaluations, and provide written informed consent