An Open Label Positron Emission Tomography (PET) Study to Evaluate Dopamine Receptor Occupancy of LB-102 Administered Orally to Healthy Subjects
| PROTOCOL NUMBER | LB-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 NAME | Mallinckrodt Institute of Radiology Washington University School of Medicine 4525 Scott Avenue St Louis MO 63110 Phone: (855) 723-3723 |
| ENROLLMENT SIZE | 16 Healthy Subjects |
| START DATE | January 2021 |
| COMPLETION DATE | October 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.
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 NUMBER | LB-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 NAME | Medpace Clinical Pharmacology Unit 5355 Medpace Way Cincinnati, OH 45227 Phone: (513) 579-9911 |
| ENROLLMENT SIZE | Single Ascending Dose (SAD): 40 Multiple Ascending Doses (MAD): 24 |
| START DATE | January 2020 |
| 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.
