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Safety and Tolerability of Single and Multiple Doses of LB-102 in Healthy Adults

NCT04187560 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-12-10

No results posted yet for this study

Summary

A Single Ascending Dose (SAD; Part A) and Multiple Ascending Dose (MAD; Part B) Phase 1 Study of LB-102 N-Methyl amisulpride) in healthy volunteers. The primary objective is to evaluate the safety and the tolerability of a single oral dose (SAD) and multiple oral doses (MAD) of LB-102 as compared to placebo. The secondary objectives are to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of LB-102.

Conditions

Interventions

DRUG

LB-102

(N-Methyl amisulpride)

Sponsors & Collaborators

  • LB Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Lukasz Biernat, MD · Medpace, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-01-22
Primary Completion
2020-07-01
Completion
2020-11-09
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 NCT04187560 on ClinicalTrials.gov