Study of Orally Administered BEBT-503 in Healthy Subjects

NCT05391880 | Completed Phase 1

• 1 other identifier: GBMT-503-P01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetic of orally administered BEBT-503 will be assessed in healthy adult subjects. The study will consist of 2 parts: a SAD phase (Part A) enrolling a total of 5 cohorts of healthy subjects; a MAD phase (Part B) enrolling 2 cohorts of healthy subjects; One cohort of Part A will receive BEBT-503 under both fasted and fed conditions to investigate the effect of food

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• single dose safety

  Number of the Adverse Events that are related to the single dose treatment from baseline to Day 10

  from baseline to Day10

• multiple dose safety

  Number of the Adverse Events that are related to the multiple dose treatment from baseline to Day 18

  from baseline to Day18

Secondary Outcomes (22)

• AUC0-∞ after single dose

  Pre-dose to 48 hours postdose

• Cmax after single dose

  Pre-dose to 48 hours postdose

• t1/2 after single dose

  Pre-dose to 48 hours postdose

• Tmax after single dose

  Pre-dose to 48 hours postdose

• CL/F after single dose

  Pre-dose to 48 hours postdose

Study Arms (2)

Drug:BEBT-503

EXPERIMENTAL

BEBT-503

Drug: BEBT-503 20mg; Drug: BEBT-503 40mg; Drug: BEBT-503 80mg; Drug: BEBT-503 120mg; Drug: BEBT-503 180mg

Drug: Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo 20mg; Drug: placebo 40mg; Drug: placebo 80mg; Drug: placebo 120mg; Drug: placebo 180mg

Interventions

BEBT-503 20mg DRUG

BEBT-503 capsule

Drug:BEBT-503

BEBT-503 40mg DRUG

BEBT-503 capsule

Drug:BEBT-503

BEBT-503 80mg DRUG

BEBT-503 capsule

Drug:BEBT-503

BEBT-503 120mg DRUG

BEBT-503 capsule

Drug:BEBT-503

BEBT-503 180mg DRUG

BEBT-503 capsule

Drug:BEBT-503

placebo 20mg DRUG

placebo capsule

Drug: Placebo

placebo 40mg DRUG

placebo capsule

Drug: Placebo

placebo 80mg DRUG

placebo capsule

Drug: Placebo

placebo 120mg DRUG

placebo capsule

Drug: Placebo

placebo 180mg DRUG

placebo capsule

Drug: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females, of any race, between 18 and 55 years of age, inclusive.
• Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) with a minimum body weight of 50 kg. Participants with a BMI up to 32.0 kg/m2 may be enrolled with the sponsor's approval
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia, eg, suspicion of Gilbert's syndrome based on total and direct bilirubin, is not acceptable) at Screening and Check-in as assessed by the Investigator (or designee), as applicable.
• Resting heart rate ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG at Screening.
• Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
• Male subjects must agree to refrain from sperm donation and females should refrain from ova donation from the date of Check-in (Day-1) until 90 days after the Follow-up visit.
• Participants have ability to swallow and retain oral medication.
• Able to comprehend and willing to sign an Information and Consent Form and to abide by the study restrictions.

You may not qualify if:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
• History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed, but not cholecystectomy).
• History of malignancy (cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ are eligible).
• Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).
• Any of the following:
• corrected QT interval by Fridericia formula\> 450 msec confirmed by repeat measurement.
• QRS duration \> 120 msec confirmed by repeat measurement.
• PR interval \> 220 msec confirmed by repeat measurement.
• findings which would make corrected QT interval measurements difficult or corrected QT interval data uninterpretable.
• history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
• History of alcoholism or drug/chemical abuse within 6 months prior to Check-in.
• Alcohol consumption of \> 21 units per week for males and \> 14 units per week for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
• Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Check-in.

Sponsors & Collaborators

• BeBetter Med Inc: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, 3004, Australia

Location

Study Officials

• Jason Lickliter, CMO

  Nucleus Network

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 26, 2022
• Study Start: August 26, 2022
• Primary Completion: May 29, 2023
• Study Completion: July 5, 2023
• Last Updated: September 18, 2023

Record last verified: 2022-05

Locations

AU (1)