drugset / Trial / NCT04187560
Safety and Tolerability of Single and Multiple Doses of LB-102 in Healthy Adults
Non-randomizedSingle-groupDouble-blindTreatment
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.
Timeline
- Start
- 2020-01-22
- Primary completion
- 2020-07-01
- Completion
- 2020-11-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | LB-102 | Small molecule | 15 mg | Oral |
| Comparator | LB-102 | Small molecule | 50 mg | Oral |
| Comparator | LB-102 | Small molecule | 75 mg | Oral |
| Comparator | LB-102 | Small molecule | 100 mg | Oral |
| Comparator | LB-102 | Small molecule | 150 mg | Oral |
| Comparator | LB-102 | Small molecule | 200 mg | Oral |