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Study of Orally Administered BEBT-503 in Healthy Subjects

NCT05391880 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2023-09-18

No results posted yet for this study

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

Interventions

DRUG

BEBT-503 20mg

BEBT-503 capsule

DRUG

BEBT-503 40mg

BEBT-503 capsule

DRUG

BEBT-503 80mg

BEBT-503 capsule

DRUG

BEBT-503 120mg

BEBT-503 capsule

DRUG

BEBT-503 180mg

BEBT-503 capsule

DRUG

placebo 20mg

placebo capsule

DRUG

placebo 40mg

placebo capsule

DRUG

placebo 80mg

placebo capsule

DRUG

placebo 120mg

placebo capsule

DRUG

placebo 180mg

placebo capsule

Sponsors & Collaborators

  • BeBetter Med Inc

    lead INDUSTRY

Principal Investigators

  • Jason Lickliter, CMO · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-26
Primary Completion
2023-05-29
Completion
2023-07-05

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05391880 on ClinicalTrials.gov