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A Phase 1, Single-Ascending-Dose Study of BT051 in Healthy Subjects

NCT05103878 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-03-28

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of single ascending doses of BT051 in healthy male or female volunteers aged 18 to \<50 years. A total of 50 subjects will be randomized to receive a single oral dose of BT051 or matching placebo in a ratio of 4 active:1 placebo in 5 ascending dose cohorts (10 subjects per cohort) at active dose levels of 100mg, 300mg, 700mg, 1500mg or 3500mg. The study Safety Review Committee (SRC) will evaluate if any dose-limiting adverse events (AEs) occurred in a cohort through Day 3, as well as review cumulative safety data for all previous cohorts and any available pharmacokinetic (PK) data before proceeding to dosing in the next cohort.

Conditions

  • Healthy Volunteers

Interventions

DRUG

BT051 100mg

Single oral dose of 100mg BT051

DRUG

BT051 300mg

Single oral dose of 300mg BT051

DRUG

BT051 700mg

Single oral dose of 700mg BT051

DRUG

BT051 1500mg

Single oral dose of 1500mg BT051

DRUG

BT051 3500mg

Single oral dose of 3500mg BT051

DRUG

Matching Placebo

Placebo Matching BT051

Sponsors & Collaborators

  • Bacainn Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Chris Stevens, MD · Bacainn Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2020-11-13
Completion
2020-11-13
FDA Drug
Yes

Countries

  • United States

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 NCT05103878 on ClinicalTrials.gov