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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 in Healthy Subjects

NCT03830125 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2020-01-18

No results posted yet for this study

Summary

This clinical trial is the first-in-human study of BBT-877. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses of BBT-877 in healthy adult subjects.

Conditions

Interventions

DRUG

BBT-877, Single dose

Single dose of BBT-877, 5 dose levels, oral capsule

DRUG

Placebo group

Placebo matched to BBT-877, oral capsule

DRUG

BBT-877, Multiple doses

Multiple doses of BBT-877, 14 days, 8 dose levels, oral capsule

Sponsors & Collaborators

  • KCRN Research, LLC

    collaborator INDUSTRY

  • Bridge Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeong-Hyun Ryou, M.D., Ph.D. · Bridge Biotherapeutics, Inc.

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
2019-02-13
Primary Completion
2019-11-24
Completion
2019-11-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03830125 on ClinicalTrials.gov