MedTrace Logo

A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers

NCT05397041 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-07-06

No results posted yet for this study

Summary

This study is designed as a single centre, double blind, placebo controlled, randomized, SAD/FE/MAD, safety, tolerance and PK study of BMB-101 in healthy adult subjects. The study will be conducted as a 3-part study.

Conditions

  • Healthy

Interventions

DRUG

BMB-101

Participants will receive one of several different oral doses of BMB-101 once or twice daily

DRUG

Placebo

Matched Placebo

Sponsors & Collaborators

  • Bright Minds Biosciences Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Michele De Sciscio · CMAX Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-06-06
Primary Completion
2023-05-04
Completion
2023-05-04

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT05397041 on ClinicalTrials.gov