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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2020-11-09

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Intervention Type DRUG

(N-Methyl amisulpride)

Interventions

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LB-102

(N-Methyl amisulpride)

Intervention Type DRUG

Other Intervention Names

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Active Drug

Eligibility Criteria

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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.
10. Have a history of blood donation in excess of 500 mL of blood within 30 days prior to Screening.
11. Have received treatment with an investigational drug or device within 30 days prior to Screening.
12. Use of any prescription or over the counter medication, herbal medications, vitamins, or supplements within 14 days prior to study drug administration.
13. Have a positive test for human immunodeficiency virus (HIV) antibodies 1 and 2, Hepatitis B surface antigen or Hepatitis C antibody.
14. Any subject who is known to be allergic to the study drug or any components of the study drug.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lukasz Biernat, MD

Role: PRINCIPAL_INVESTIGATOR

Medpace, Inc.

Locations

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Medpace Clinical Pharmacology LLC

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Study Documents

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Document Type: Clinical Study Report

View Document

Other Identifiers

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LB-102-001

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Part A Cohort 1

LB-102

Part A Cohort 2

LB-102

Part A Cohort 3

LB-102

Part A Cohort 4

LB-102

Part A Cohort 5

LB-102

Part B Cohort 6

LB-102

Part B Cohort 7

LB-102

Part B Cohort 8

LB-102

Interventions

LB-102

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

LB Pharmaceuticals Inc.

Responsible Party

Principal Investigators

Lukasz Biernat, MD

Locations

Medpace Clinical Pharmacology LLC

Countries

Study Documents

Document Type: Clinical Study Report

Related Links

Other Identifiers

LB-102-001