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First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Volunteers

NCT03482648 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-07-21

No results posted yet for this study

Summary

This clinical trial is the first-in-human study of BBT-401-1S. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses of BBT-401-1S in healthy adult subjects.

Conditions

Interventions

DRUG

BBT-401-1S, Single dose

Single dose of BBT-401-1S, 7 dose levels, oral capsule

DRUG

BBT-401-1S, Multiple doses

Multiple doses of BBT-401-1S, 7 days, 3 dose levels, oral capsule

DRUG

Placebo

Placebo matched to BBT-401-1S, oral capsule

Sponsors & Collaborators

  • KCRN Research, LLC

    collaborator INDUSTRY

  • Bridge Biotherapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2018-09-26
Completion
2018-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03482648 on ClinicalTrials.gov