CompletedNCT04187560Updated Dec 10, 2020

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

A Phase 1 interventional study of LB-102 in Schizophrenia, sponsored by LB Pharmaceuticals Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-10.

Sponsored by LB Pharmaceuticals Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Jul 2020, 6 years 3 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 64
Allocation: Non-randomized
Ages: 18 Years to 55 Years
Sex: All

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.

Read the 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.

Conditions studied

Schizophrenia

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Schizophrenia 3,471

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 64 is close to the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

LB Pharmaceuticals Inc. is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Subjects may be included in the study only if they meet all of the following criteria:

Competent to provide informed consent.
Voluntarily provide informed consent.
Healthy adult male and female subjects between 18 to 55 years of age inclusive at the screening visit.
Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2 at screening visit.
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.
Have normal clinical laboratory test results and ECG, which are not considered to be clinically significant by the investigator.
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.
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:
Male subjects must agree to abstain from sperm donation through 90 days after administration of the last dose of investigational drug.

Exclusion criteria

Exclusion Criteria:

Subjects will be excluded from the study for any of the following reasons:

Are pregnant or lactating.
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.
Clinically significant abnormal findings on physical examination, vital signs, or ECG.
History or presence of psychiatric or neurological disease or condition.
History of seizures.
Subject with any history or current evidence of suicidal behavior.
Unwilling to complete any planned study assessments, including the Columbia-Suicide Severity Rating Scale (CSSRS).
Recent history of alcohol or drug abuse (within the last two years).
Any use of tobacco or tobacco-containing products (cigarettes, pipes, etc.) within one month prior to screening.
Have a history of blood donation in excess of 500 mL of blood within 30 days prior to Screening.
Have received treatment with an investigational drug or device within 30 days prior to Screening.
Use of any prescription or over the counter medication, herbal medications, vitamins, or supplements within 14 days prior to study drug administration.
Have a positive test for human immunodeficiency virus (HIV) antibodies 1 and 2, Hepatitis B surface antigen or Hepatitis C antibody.
Any subject who is known to be allergic to the study drug or any components of the study drug.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: Double (Participant, Care provider)
Enrollment: 64 participants (actual)

Study arms

Active comparator
Part A Cohort 1
LB-102 50 mg (n=6) or Matching Placebo (n=2) x 1 day
Drug: LB-102
Active comparator
Part A Cohort 2
LB-102 15 mg (n=6) or Matching Placebo (n=2) x 1 day
Drug: LB-102
Active comparator
Part A Cohort 3
LB-102 100 mg (n=6) or Matching Placebo (n=2) x 1 day
Drug: LB-102
Active comparator
Part A Cohort 4
LB-102 200 mg (n=6) or Matching Placebo (n=2) x 1 day
Drug: LB-102
Active comparator
Part A Cohort 5
LB-102 150 mg (n=6) or Matching Placebo (n-2) x 1 day
Drug: LB-102
Active comparator
Part B Cohort 6
LB-102 50 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7)
Drug: LB-102
Active comparator
Part B Cohort 7
LB-102 100 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7)
Drug: LB-102
Active comparator
Part B Cohort 8
LB-102 75 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7)
Drug: LB-102

Interventions

DrugLB-102
(N-Methyl amisulpride)
Also known as: Active Drug

What researchers measure

Primary outcomes

Percentage of participants who experience at least one treatment-emergent adverse event (TEAE)
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing.
Time frame: Day 8 (Part A) or Day 15 (Part B)

Secondary outcomes

Tmax: Time to Reach the Maximum Plasma Concentration
Time to reach the maximum observed plasma concentration for LB-102 and LB-102 metabolite amisulpride after a single dose (Day 1) and multiple dosing (Day 7).
Time frame: Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)
Cmax: Maximum Observed Plasma Concentration
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Cmax will be measured for LB-102 and LB-102 metabolite amisulpride after a single dose (Day 1) and multiple dosing (Day 7).
Time frame: Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration
AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the Last Quantifiable Concentration and will be measured for LB-102 and LB-102 metabolite amisulpride after a single dose (Day 1) and multiple dosing (Day 7)
Time frame: Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose
AUC(0-24) is a measure of total plasma exposure to the drug from Time 0 to 24 hours post-dose for LB-102 and LB-102 metabolite amisulpride after a single dose (Day 1) and multiple dosing (Day 14).
Time frame: Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)

Study locations

1 site

Medpace Clinical Pharmacology LLC
Cincinnati, Ohio 45227, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04187560
Lead sponsor: LB Pharmaceuticals Inc.
Responsible party: Sponsor
First posted: Dec 5, 2019
Start date: Jan 22, 2020
Primary completion: Jul 1, 2020
Completion: Nov 9, 2020
Last update: Dec 10, 2020

Study contacts

Lukasz Biernat, MD

principal investigator · Medpace, Inc.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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