A Randomized, Double-Blind, Placebo-Controlled Study of Orally Administered BEBT-503 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) in Healthy Subjects

BeBetter Med Inc1 site in 1 country57 target enrollmentAugust 26, 2022

Overview

Phase: Phase 1
Intervention: BEBT-503 40mg
Conditions: Healthy Subjects
Sponsor: BeBetter Med Inc
Enrollment: 57
Locations: 1
Primary Endpoint: multiple dose safety
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 26, 2022

End Date

July 5, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

BeBetter Med Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Intervention: placebo 180mg

Outcomes

Primary Outcomes

multiple dose safety

Time Frame: from baseline to Day18

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

single dose safety

Time Frame: from baseline to Day10

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

Secondary Outcomes

Vz/F after single dose(Pre-dose to 48 hours postdose)
AUC0-∞ after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
AUC0-∞ after single dose(Pre-dose to 48 hours postdose)
t1/2 after single dose(Pre-dose to 48 hours postdose)
Cmax 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)
AUC0-τ after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
Cmax after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
t1/2 after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
Tmax after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
Cmin after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
RAAUC0-τ after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
RACmax after multiple dose(Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose)
effect of food on the single oral dose AUC0-∞(Pre-dose to 48 hours postdose)
effect of food on the single oral dose Cmax(Pre-dose to 48 hours postdose)
effect of food on the single oral dose Tmax(Pre-dose to 48 hours postdose)
effect of food on the single oral dose t1/2(Pre-dose to 48 hours postdose)
effect of food on the single oral dose CL/F(Pre-dose to 48 hours postdose)
effect of food on the single oral dose Vz/F(Pre-dose to 48 hours postdose)
metabolites of BEBT-503 in urine(Pre-dose to 48 hours postdose)
metabolites of BEBT-503 in plasma(Pre-dose to 48 hours postdose)