A Phase 1 Study of SMP-100 in Normal Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title: Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of SMP-100 in Normal Healthy Volunteers

Status Completed

Clinical Trial Summary

This will be the first clinical study of oral administration SMP-100 in healthy subjects. The proposed randomized Phase 1 trial is a double-blind, placebo-controlled, single and multiple ascending dose study in approximately 72 healthy male and female subjects.

Clinical Trial Description

SMP-100 is a novel serotonin receptor 3 (5-HT3) partial agonist which has been designed to be a safe and effective therapy for irritable bowel syndrome (IBS) patients .

This will be a single center, Phase 1, double-blind, placebo-controlled, randomized, sequential single ascending dose (SAD)/ multiple ascending dose (MAD) study to assess the safety, tolerability, and PK of SMP-100 in healthy adult male and female subjects. The study will be divided into two parts:

Part A: SAD cohorts Part A will consist of 6 cohorts (1 cohort per dose level) of 8 subjects (6 subjects receiving the study drug and 2 receiving matching placebo), for a total of 48 subjects. Each subject will participate in only one cohort. Efforts will be made to randomize at least 3 subjects of each gender in each cohort.

Part B: MAD cohorts Part B will consist of 3 cohorts (1 cohort per dose level) of 8 subjects. Six subjects will receive study drug and 2 subjects will receive matching placebo, daily for 14 consecutive days, for a total of 24 subjects (18 study drug; 6 placebo). Each study subject will participate in only one cohort. Efforts will be made to randomize at least 3 subjects of each gender in each cohort.

For both Part A and Part B, subjects who withdraw or are withdrawn from the study after dosing, for reasons other than safety and tolerability, may be replaced after consultation between the Safety Review Committee (SRC) members. The total number of subjects dosed (including potential replacement subjects) will remain within a maximum of 10 subjects per cohort. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT04296799
• Study type: Interventional
• Source: Chengdu SciMount Pharmatech Co., Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: June 25, 2020
• Completion date: August 6, 2021