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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07905053




Registration number
Help: Registration number
NCT07905053
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
23/10/2026
Date registered
Help: Date registered
29/10/2026
Date last updated
Help: Date last updated
29/10/2026

Titles & IDs
Public title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Scientific title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Additional trial identifiers [1] 0 0
CBT-248-HV-P1
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Chronic Pancreatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - CBT-248
Treatment: Drugs - CBT-248 Placebo
Other interventions - Fasted - Period 1
Other interventions - Fed - Period 2

Experimental: Cohort A1 - SAD Cohort A1, receiving one 150mg dose of CBT-248, or Placebo (n=8; 6 active treatment and 2 placebo).

Experimental: Cohort A2 - 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).

Experimental: Cohort A3 - 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).

Experimental: Cohort A4 - 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).


Treatment: Drugs: CBT-248
CBT-248 will be administered as oral vegetable (cellulose) capsules.

Treatment: Drugs: CBT-248 Placebo
The Placebo equivalent of CBT-248 will be administered as oral vegetable (cellulose) capsules that visually match the active treatment.

Other interventions: Fasted - Period 1
Participants will receive one dose of CBT-248 on Day 1 of Period 1 (fasted) after approximately 10 hours of fasting.

Other interventions: Fed - Period 2
Participants will receive one dose of CBT-248 on Day 1 of Period 2 (fed) 30 minutes after a high-fat/high-calorie meal.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Adverse Events (AEs), as assessed by a 5-point scale, CTCAE v5.0.
Timepoint [1] 0 0
Continuously monitored from Baseline (Day -1) to end-of-study (SAD: Day 7; FE: Day 7 of Period 2).
Secondary outcome [1] 0 0
Maximum plasma concentration of CBT-248 in the blood (as part of pharmacokinetic or 'PK' testing)
Timepoint [1] 0 0
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).
Secondary outcome [2] 0 0
Time to maximum plasma concentration of CBT-248 in the blood (as part of pharmacokinetic or 'PK' testing).
Timepoint [2] 0 0
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).
Secondary outcome [3] 0 0
Area under the drug concentration-time curve of CBT-248 in the blood (as part of pharmacokinetic or 'PK' testing)
Timepoint [3] 0 0
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).
Secondary outcome [4] 0 0
Clearance of CBT-248 in the blood (as part of pharmacokinetic or 'PK' testing).
Timepoint [4] 0 0
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).

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/10/2026
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cibus Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Avance Clinical Pty Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Honit Piplani
Address 0 0
Cibus Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07905053