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Safety and Tolerability of Single and Multiple Doses of LB-102 in Healthy Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Randomized, Double-blinded, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LB-102 Administered Orally to Healthy Subjects

NCT04187560•LB Pharmaceuticals Inc.

View on ClinicalTrials.gov

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.

Detailed Description

This is a Phase 1, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of LB-102 in healthy subjects. The study will consist of two parts: Part A - Single Ascending Dose and Part B - Multiple Ascending Doses. There will be 5 cohorts in Part A and 3 Cohorts in Part B of this study. Each cohort consists of 8 subjects, with 6 subjects assigned to LB-102 and 2 subjects assigned to placebo. In Parts A and B, eligible subjects will be randomized on Day 1 (pre-dose) to placebo (n=2) or LB-102 (n=6). Eligible subjects will receive 1 dose on Day 1 (Part A) or 13 doses on Days 1-7 (Part B) of placebo or LB-102.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects may be included in the study only if they meet all of the following criteria:
•1. Competent to provide informed consent.
•2. Voluntarily provide informed consent.
•3. Healthy adult male and female subjects between 18 to 55 years of age inclusive at the screening visit.
•4. Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2 at screening visit.
•5. Subjects must be in good general health as determined by medical history and physical examination with no clinically significant medical findings and no history of significant medical disease (e.g. cardiovascular, pulmonary, renal, etc.) or acute condition with the past 30 days.
•6. Have normal clinical laboratory test results and ECG, which are not considered to be clinically significant by the investigator.
•7. Female subjects of child-bearing potential must agree to use two methods of an acceptable method of birth control (e.g., condom and spermicide, intrauterine device (IUD), oral contraception which has been stable for 30 days) and at least 90 days after stopping the investigational product. Female subjects using oral contraception whose partner consistently uses condoms or who is vasectomized is also acceptable.
•8. Male subjects must be surgically sterile or practicing at least one method of contraception, from initial study drug administration through 90 days after administration of the last dose of study drug:
•9. Male subjects must agree to abstain from sperm donation through 90 days after administration of the last dose of investigational drug.

Exclusion Criteria

•Subjects will be excluded from the study for any of the following reasons:
•1. Are pregnant or lactating.
•2. Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders which, in the opinion of the investigator, increases the risk of the study drug or may confound the interpretation of study measures.
•3. Clinically significant abnormal findings on physical examination, vital signs, or ECG.
•4. History or presence of psychiatric or neurological disease or condition.
•5. History of seizures.
•6. Subject with any history or current evidence of suicidal behavior.
•7. Unwilling to complete any planned study assessments, including the Columbia-Suicide Severity Rating Scale (CSSRS).
•8. Recent history of alcohol or drug abuse (within the last two years).
•9. Any use of tobacco or tobacco-containing products (cigarettes, pipes, etc.) within one month prior to screening.
+5 more criteria

Locations (1)

Medpace Clinical Pharmacology LLC

Cincinnati, Ohio, United States

Key Dates

Start Date

January 22, 2020

Primary Completion Date

July 1, 2020

Completion Date

November 9, 2020

Last Updated

December 10, 2020

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

LB-102

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

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Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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