Chronic PancreatitisPhase 1NCT07905053
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
A Phase 1 study testing CBT-248, Fasted - Period 1 and Fed - Period 2 in people with Chronic Pancreatitis, run by Cibus Therapeutics, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- CBT-248, Fasted - Period 1 and Fed - Period 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Oct 2026to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males and females, 18 to 55 years of age (inclusive) at Screening.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive) at Screening.
- Medically healthy (in the opinion of the PI or delegate), as determined by pre-study medical history, and without clinically significant (CS) abnormalities after physical examination.
- Female volunteers must be of non-childbearing potential or be willing to avoid pregnancy by using adequate contraception.
- Male volunteers must agree not to donate sperm and to use adequate contraception with female partners.
Who cannot join
- Known hypersensitivity to the study drug or any of the study drug ingredients, or history of anaphylaxis or other significant allergy which, in the opinion of the PI (or delegate), would interfere with the volunteer's ability to participate in the study.
- Clinically significant infection and/or cardiovascular, haematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the participant's risk if they were to participate in the study.
- History or current evidence of a clinically significant breast mass, unexplained nipple discharge, suspicious breast imaging, or other findings suggestive of clinically significant breast pathology that, in the opinion of the Investigator, could increase participant risk or interfere with study participation.
- Unable or unwilling to comply with the required soy-restricted dietary periods specified in the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
Dr Aarthy Joseph, +61 3 8593 9801, a.joseph@nucleusnetwork.com.au
About this study
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.
Read more
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.
- Conditions
- Chronic Pancreatitis
- Being tested
- CBT-248, CBT-248 Placebo, Fasted - Period 1, Fed - Period 2
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-248Drug
CBT-248 will be administered as oral vegetable (cellulose) capsules.
CBT-248 PlaceboDrug
The Placebo equivalent of CBT-248 will be administered as oral vegetable (cellulose) capsules that visually match the active treatment.
Fasted - Period 1Other
Participants will receive one dose of CBT-248 on Day 1 of Period 1 (fasted) after approximately 10 hours of fasting.
Fed - Period 2Other
Participants will receive one dose of CBT-248 on Day 1 of Period 2 (fed) 30 minutes after a high-fat/high-calorie meal.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1 | Experimental | SAD Cohort A1, receiving one 150mg dose of CBT-248, or Placebo (n=8; 6 active treatment and 2 placebo). Receives: Drug: CBT-248; Drug: CBT-248 Placebo |
| Cohort A2 | Experimental | 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). Receives: Drug: CBT-248; Drug: CBT-248 Placebo |
| Cohort A3 | Experimental | 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). Receives: Drug: CBT-248; Drug: CBT-248 Placebo; Other: Fasted - Period 1; Other: Fed - Period 2 |
| Cohort A4 | Experimental | 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). Receives: Drug: CBT-248; Drug: CBT-248 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Continuously monitored from Baseline (Day -1) to end-of-study (SAD: Day 7; FE: Day 7 of Period 2).
Secondary outcomes (4)
Maximum plasma concentration of CBT-248 in the blood (as part of pharmacokinetic or 'PK' testing)
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start15 Oct 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cibus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Honit Piplani, Study director, Cibus Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905053
- Sponsor's protocol ID
- CBT-248-HV-P1
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07905053
- Acronym / sponsor ID
- CBT-248-HV-P1
- Conditions
- Chronic Pancreatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cibus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A1 | Experimental | Drug: CBT-248, Drug: CBT-248 PlaceboSAD Cohort A1, receiving one 150mg dose of CBT-248, or Placebo (n=8; 6 active treatment and 2 placebo). |
| Cohort A2 | Experimental | Drug: CBT-248, Drug: CBT-248 PlaceboSAD 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). |
| Cohort A3 | Experimental | Drug: CBT-248, Drug: CBT-248 Placebo, Other: Fasted - Period 1, Other: Fed - Period 2FE 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). |
| Cohort A4 | Experimental | Drug: CBT-248, Drug: CBT-248 PlaceboSAD 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult males and females, 18 to 55 years of age (inclusive) at Screening.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive) at Screening.
- Medically healthy (in the opinion of the PI or delegate), as determined by pre-study medical history, and without clinically significant (CS) abnormalities after physical examination.
- Female volunteers must be of non-childbearing potential or be willing to avoid pregnancy by using adequate contraception.
- Male volunteers must agree not to donate sperm and to use adequate contraception with female partners.
Key exclusion criteria (4 listed)
- Known hypersensitivity to the study drug or any of the study drug ingredients, or history of anaphylaxis or other significant allergy which, in the opinion of the PI (or delegate), would interfere with the volunteer's ability to participate in the study.
- Clinically significant infection and/or cardiovascular, haematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the participant's risk if they were to participate in the study.
- History or current evidence of a clinically significant breast mass, unexplained nipple discharge, suspicious breast imaging, or other findings suggestive of clinically significant breast pathology that, in the opinion of the Investigator, could increase participant risk or interfere with study participation.
- Unable or unwilling to comply with the required soy-restricted dietary periods specified in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-248CBT-248 will be administered as oral vegetable (cellulose) capsules. | Drug | Cohort A1, Cohort A2, Cohort A3, Cohort A4 |
| CBT-248 PlaceboThe Placebo equivalent of CBT-248 will be administered as oral vegetable (cellulose) capsules that visually match the active treatment. | Drug | Cohort A1, Cohort A2, Cohort A3, Cohort A4 |
| Fasted - Period 1Participants will receive one dose of CBT-248 on Day 1 of Period 1 (fasted) after approximately 10 hours of fasting. | Other | Cohort A3 |
| Fed - Period 2Participants will receive one dose of CBT-248 on Day 1 of Period 2 (fed) 30 minutes after a high-fat/high-calorie meal. | Other | Cohort A3 |
Primary outcome
Number of participants with Adverse Events (AEs), as assessed by a 5-point scale, CTCAE v5.0.
Time frame: Continuously monitored from Baseline (Day -1) to end-of-study (SAD: Day 7; FE: Day 7 of Period 2).
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).
4 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Honit Piplani study director
Cibus Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBT-248, Fasted - Period 1 and Fed - Period 2 in people with Chronic Pancreatitis, run by Cibus Therapeutics, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs), as assessed by a 5-point scale, CTCAE v5.0. (time frame: Continuously monitored from Baseline (Day -1) to end-of-study (SAD: Day 7; FE: Day 7 of Period 2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.