This is a multicenter, open-label, non-randomized, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160. Both products are mRNA encapsulated in lipid nanoparticles (LNPs).

The purpose of the study is to determine the changes in muscle metabolites by MRI before and after exercise. The MRI will be performed while performing mild exercise of the calf muscle for 1-3 minutes.  We are actively recruiting adults between 45-55 and 70-84.  Volunteers cannot have diabetes, liver disease, kidney disease, or anemia.  

The purpose of this research study is to test how high blood sugar develops and worsens over time in some people with cystic fibrosis.If you agree to take part, your participation can last for up to 7 years.As a participant in this research, all participants will:Complete overnight fastingComplete Mixed Meal Tolerance Tests (MMTT) to test your body’s response to food. This procedure will be completed up to four times over the course of 5 years.Complete DXA scans, which measure the amount of fat and lean (non-fat) tissue in the body. This procedure will be completed up to four times over the course of 5 years.Complete questionnaires related to physical activity and diet.Have research blood and urine tests.For participants who have not had OGTTs done clinically in the past 6 months:Complete Oral Glucose Tolerance Tests (OGTT). The OGTT tests your body’s response to sugar. This procedure will be completed up to four times. 

The study is designed to test the idea that branched chain amino acids, a specific component of all protein, and fat combine to cause a temporary state of insulin resistance. Insulin resistance is a condition that occurs when your body demands more insulin to control your blood sugar level. Branched chain amino acids are building blocks for protein found in nearly everything we eat. There are three branched­ chain amino acids: valine, leucine, and isoleucine, and we are measuring the effect of valine, leucine, or all three combined.  Specifically, we will test the effect of these amino acids in healthy individuals. We hope to find out whether branched chain amino acids cause a temporary state of insulin resistance.  We will compare your insulin sensitivity in response to low-dose fat infusion plus either valine, leucine, all three amino acids combined, or a placebo.