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

NCT04296799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-03-11

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

SMP-100

SAD/MAD

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Chengdu SciMount Pharmatech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Sepehr Shakib · CMAX Clinical Research Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2021-07-26
Completion
2021-08-06
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04296799 on ClinicalTrials.gov