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A Study of SENS 401 in Healthy Subjects

NCT03071003 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-04-08

No results posted yet for this study

Summary

Sensorion are the study sponsor and the objective of this study is to investigate the safety and pharmacokinetic (PK) profile of SENS 401 in humans after a single and repeat dose administration and to confirm that, there is no interconversion of the (R) enantiomer to the (S) enantiomer.

The study only involves the one drug, referred to as SENS-401.The key objective is to assess the safety of SENS 401 after multiple doses in healthy subjects.

The population who are eligible to take part in the study are healthy male and female, non-smoking volunteers, aged between 18 and 50 years, as determined by screening tests at Simbec.

Participation in the trial will last for about 3 weeks (from first screening to final end of study visit).

Conditions

  • Inner Ear Disease

Interventions

DRUG

SENS-401

Oral Administration

DRUG

Placebo

Oral Administration

Sponsors & Collaborators

  • Sensorion

    collaborator INDUSTRY

  • Simbec Research

    lead INDUSTRY

Principal Investigators

  • Robert Adams, MBBS · Simbec Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2016-10-21
Primary Completion
2017-03-21
Completion
2017-10-16

Countries

  • United Kingdom

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 NCT03071003 on ClinicalTrials.gov