A Phase 1 interventional study of CBT-248 and CBT-248 Placebo in Chronic Pancreatitis, sponsored by Cibus Therapeutics, Inc.. Recruiting at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Cibus Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
264 studies on the registry are indexed under Pancreatitis, Chronic; 76 are open to participants now.
This study's planned enrollment of 32 is below the median of 45 across 143 interventional studies indexed under Pancreatitis, Chronic.
Browse Pancreatitis, Chronic studies →This is the only study on the registry with Cibus Therapeutics, Inc. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SAD Cohort A1, receiving one 150mg dose of CBT-248, or Placebo (n=8; 6 active treatment and 2 placebo).
Drug: CBT-248 · Drug: CBT-248 Placebo
SAD Cohort A2, receiving one dose of CBT-248 at the second planned dose level (Dose 2), or Placebo (n=8; 6 active treatment and 2 placebo).
Drug: CBT-248 · Drug: CBT-248 Placebo
FE Cohort A3, receiving two doses of CBT-248 at the third planned dose level (Dose 3), or Placebo (or Placebo (n=8; 6 active treatment and 2 placebo).
Drug: CBT-248 · Drug: CBT-248 Placebo · Other: Fasted - Period 1 · Other: Fed - Period 2
SAD Cohort A4, receiving one dose of CBT-248 at the fourth planned dose level (Dose 4), or Placebo (n=8; 6 active treatment and 2 placebo).
Drug: CBT-248 · Drug: CBT-248 Placebo
CBT-248 will be administered as oral vegetable (cellulose) capsules.
The Placebo equivalent of CBT-248 will be administered as oral vegetable (cellulose) capsules that visually match the active treatment.
Participants will receive one dose of CBT-248 on Day 1 of Period 1 (fasted) after approximately 10 hours of fasting.
Participants will receive one dose of CBT-248 on Day 1 of Period 2 (fed) 30 minutes after a high-fat/high-calorie meal.
Number of participants with Adverse Events (AEs), as assessed by a 5-point scale, CTCAE v5.0.
Adverse event monitoring includes measuring the frequency, severity and relationship of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) leading to treatment or study discontinuation. Severity of adverse events will be characterized from 1 (mild) to 5 (death).
Time frame: Continuously monitored from Baseline (Day -1) to end-of-study (SAD: Day 7; FE: Day 7 of Period 2).
Maximum plasma concentration of CBT-248 in the blood (as part of pharmacokinetic or 'PK' testing)
Time frame: All SAD Cohorts, and FE Period 1 and Period 2: Day -6; Day -2 (Admission); 1 hr pre-dose on Day 1; 5, 15 and 30 mins post-dose; 1, 1.5, 2, 4, 6, 8, 10, 16 and 24 hrs post-dose; and Day 7 (Follow-Up).
Time to maximum plasma concentration of CBT-248 in the blood (as part of pharmacokinetic or 'PK' testing).
Time frame: All SAD Cohorts, and FE Period 1 and Period 2: Day -6; Day -2 (Admission); 1 hr pre-dose on Day 1; 5, 15 and 30 mins post-dose; 1, 1.5, 2, 4, 6, 8, 10, 16 and 24 hrs post-dose; and Day 7 (Follow-Up).
Area under the drug concentration-time curve of CBT-248 in the blood (as part of pharmacokinetic or 'PK' testing)
Time frame: All SAD Cohorts, and FE Period 1 and Period 2: Day -6; Day -2 (Admission); 1 hr pre-dose on Day 1; 5, 15 and 30 mins post-dose; 1, 1.5, 2, 4, 6, 8, 10, 16 and 24 hrs post-dose; and Day 7 (Follow-Up).
Clearance of CBT-248 in the blood (as part of pharmacokinetic or 'PK' testing).
Time frame: All SAD Cohorts, and FE Period 1 and Period 2: Day -6; Day -2 (Admission); 1 hr pre-dose on Day 1; 5, 15 and 30 mins post-dose; 1, 1.5, 2, 4, 6, 8, 10, 16 and 24 hrs post-dose; and Day 7 (Follow-Up).
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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