CBT-248 safety in healthy adults for chronic pancreatitis support

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial will assess the safety, tolerability, and pharmacokinetics of CBT-248 in 32 healthy adults aged 18 to 55. Participants are divided into four groups of eight, with six receiving CBT-248 and two receiving placebo in each group, in a randomized, double-blind design. The study will compare fasting and fed conditions to determine if food changes the drug’s exposure. Dosing occurs after fasting in three groups, with inpatient evaluation around the dosing and follow-up checks.

Why it matters

Who can join: the full rules

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.

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.

Where it's running

• Nucleus Network Pty Ltd
  Melbourne, Victoria, Australia Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.