A Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers

This is a Phase 1 safety study for a new experimental drug called BT-11, which is being tested in healthy adults for the first time. Phase 1 trials are the earliest stage of human testing and are focused entirely on understanding how safe and well-tolerated a drug is, and how the body processes it — not on treating any specific disease. BT-11 is a novel compound, and this study aims to establish what doses are safe before any further trials are conducted. Participants receive either BT-11 or a placebo (an inactive substance) in increasing doses over several testing sessions. There are two phases: a single dose phase, where participants receive one dose only, and a multiple dose phase, where participants take the drug for 7 consecutive days. Blood samples are collected at regular intervals to track how the drug moves through the body. Participants are carefully monitored throughout. You may be eligible if you are a healthy adult aged 18 to 65, weigh between 65 and 85 kg, have a BMI between 19 and 31, and are not taking any other medications. You must be willing to avoid alcohol and all medications for the duration of the study. People with any significant medical conditions, a history of drug or alcohol abuse, or who have previously participated in another drug trial within 30 days are not eligible.