Clinical Research Directory

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants

Sponsor: Cibus Therapeutics, Inc.

Summary

This study will test CBT-248, an experimental medicine being developed for chronic pancreatitis. Chronic pancreatitis causes ongoing inflammation and damage to the pancreas, which can cause pain and problems with digestion and blood sugar control. The study will involve 32 healthy adults. It will look at side effects at different doses, measure the amount of medicine in the blood over time, and examine whether taking it with food changes these amounts. Participants will be divided into four groups of eight. In each group, six people will receive CBT-248 and two will receive a placebo, a capsule that looks like the medicine but contains no active drug. Treatment will be assigned by chance. Participants and the study staff assessing them will not know who receives CBT-248 or placebo. Three groups will receive one dose after fasting. Participants will enter the clinic two days before dosing and may leave the day after dosing, once the required checks are complete. They will return for follow-up visits four and six days after dosing. The fourth group will receive two doses on separate occasions: one after fasting and one after starting a high-fat, high-calorie meal. Each person will receive the same treatment, CBT-248 or placebo, on both occasions. The second dose will be given after the required safety results and measurements of medicine levels have been reviewed. Each occasion will involve a clinic stay and follow-up visits as described above. During the study, participants will have blood tests, physical examinations, checks of blood pressure and other vital signs, and tests that record the heart's electrical activity. The study team will also ask about side effects.

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