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Pharmacokinetics and Pharmacodynamics Study of LBS-008 in Healthy Volunteers Aged 50-85

NCT05667688 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-02-23

No results posted yet for this study

Summary

This is a Phase 1b, parallel single-dose study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of Tinlarebant when administered as an oral dose to elderly healthy volunteers. This study will evaluate 2 dose levels in 2 cohorts comprising up to a total of 16 participants (8 per cohort). Dose levels will be evaluated in parallel.

Conditions

Interventions

DRUG

Tinlarebant (LBS-008)

A single dose of Tinlarebant (LBS-008) will be administered to each study participant on study Day 1.

Sponsors & Collaborators

  • Belite Bio, Inc

    collaborator INDUSTRY

  • RBP4 Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Sam Francis · Nucleus Network - Melbourne

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-28
Primary Completion
2023-01-04
Completion
2023-01-18
FDA Drug
Yes

Countries

  • Australia

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 NCT05667688 on ClinicalTrials.gov