MedTrace Logo

Safety and Tolerability Study of LBS-008 in Healthy Adult Subjects After Single and Multiple Doses

NCT03735810 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2020-01-07

No results posted yet for this study

Summary

This is a single center, randomized, double-blind, placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study is planned to assess safety, pharmacokinetics (PK), and pharmacodynamics of LBS-008 in healthy adult volunteers.

Conditions

  • Healthy Volunteer

Interventions

DRUG

LBS-008

LBS-008 oral capsules

DRUG

Placebos

Oral capsules

Sponsors & Collaborators

  • Belite Bio, Inc

    collaborator INDUSTRY

  • RBP4 Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2019-09-16
Completion
2019-09-16
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

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 NCT03735810 on ClinicalTrials.gov