An Open Label Positron Emission Tomography (PET) Study to Evaluate Dopamine Receptor Occupancy of LB-102 Administered Orally to Healthy Subjects

PROTOCOL NUMBERLB-102-002
STUDY PHASE
Phase 1b
IND NUMBER
137581
CONTRACT RESEARCH ORGANIZATION
Target Health Inc.
261 Madison Ave. Floor 24
New York, NY 10016
Phone: (212) 681-2100
INVESTIGATOR NAME
Dr. Dean Wong, MD
INSTITUTION NAMEMallinckrodt Institute of Radiology
Washington University School of Medicine
4525 Scott Avenue
St Louis MO 63110
Phone: (855) 723-3723
ENROLLMENT SIZE16 Healthy Subjects
ESTIMATED START DATE
November 2020
ESTIMATED COMPLETION DATE
March 2021

Clinical Program Study Design: This is a Phase 1, open label study designed to evaluate the dopamine receptor occupancy in healthy subjects. There will be 4 cohorts consisting of 4 subjects each. Eligible subjects will receive 1 or 2 doses of LB-102 on Day 1: subjects in the final cohort will be dosed for 5 days BID on an inpatient basis. This will be an open label study. Blood samples for PK and safety assessments will be collected at screening, immediately pre-dose, and during/before/after PET scan. Subjects enrolled in the inpatient cohort will be monitored daily. Follow-up after discharge will consist of a phone call the evening of discharge and the next day to check on subjects. This will be an adaptive study and doses in cohorts 2-4 will be determined after PET data from Cohort 1 are obtained.

Additional Information:

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

PROTOCOL NUMBERLB-102-001
STUDY PHASE
Phase 1
IND NUMBER
137581
CONTRACT RESEARCH ORGANIZATION
Target Health Inc.
261 Madison Ave. Floor 24
New York, NY 10016
Phone: (212) 681-2100
INVESTIGATOR NAME
Lukasz Biernat, MD (cohorts 1 - 4)
Leela Vrishabhendra, MD (cohorts 5 - 8)
INSTITUTION NAMEMedpace Clinical Pharmacology Unit
5355 Medpace Way
Cincinnati, OH 45227
Phone: (513) 579-9911
ENROLLMENT SIZESingle Ascending Dose (SAD): 40
Multiple Ascending Doses (MAD): 24
ESTIMATED START DATE
January 2020
ESTIMATED COMPLETION DATE
August 2020

Clinical Program Study Design: 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 (ie. SAD & MAD). 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 treatment and 2 subjects assigned to placebo treatment.

Additional Information:

Results:

Please note that both the Investigator’s Brochure and Protocol are likely to be amended from time to time until the completion of the study. We will endeavor to update the file(s) whenever amendments are made but cannot guarantee the timeliness of updating this website.

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