Official Title A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Escalating Doses of LH-001 in Healthy Subjects

Purpose

The purpose of this study is to evaluate the safety and tolerability of an investigational new drug in healthy participants aged 18-60 years.

Could this study be right for you?

• In good health and BMI (ratio of body weight to height) between 18-26 kg/m2
• Willing to participate in various research assessments including blood collection, urine collection, electrocardiogram, and vital signs
• Willing to stay overnight (~30 hours) in the OSU Hospital Clinical Research Center
• If sexually active, willing to utilize highly effective birth control during the study period
• Not currently pregnant or breast-feeding
• No any significant medical condition involving any major organs (heart, lung, liver, brain, or endocrine)
• No any of the following: cancer, alcohol or substance abuse, spleen problems, or drug hypersensitivity
• No history of or undergoing treatment for: major psychiatric illness, seizures, or autoimmune disease
• Not currently taking immunosuppressive drugs
• No active Hepatitis B, Hepatitis C, or HIV

Age Range

18 - 60 years