A Phase I/II Randomised, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of a Live Biotherapeutic Product (SVT-4A1011) in Adults with Clinically Diagnosed Insomnia

Servatus Ltd0 sites50 target enrollmentOctober 20, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 20, 2021

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\.Male and female Participants aged 18 to 70 years, capable of providing written informed consent and able to attend the study site on up to 4 separate occasions,
•2\.Insomnia Severity Index (ISI) score greater than or equal to 8 with insomnia symptoms for more than 3 times per week and present for longer than 3 months,
•3\.Clinical diagnosis of Insomnia determined by clinical interview conducted by a trained sleep psychologist,
•4\.Females of childbearing potential (FOCBP) must have a negative pregnancy test at the Baseline Visit. While on the study, FOCBP who engage in activity in which conception is possible, must use one of the approved contraceptive options described below:
•a.Hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring),
•b.Intrauterine device (IUD),
•c.Tubal Ligation,
•d.Partner’s Vasectomy, or
•e.Barrier method i.e., male or female condom.
•5\.Male Participants who have not had a vasectomy and who engage in activity in which conception is possible, must use barrier contraception i.e., male condom while on study, or if their partner is FOCBP, the partner can use hormonal contraception, an IUD or have had a tubal ligation.

•1\.Sleep apnoea (AHI greater than 10\) determined by PSG,
•2\.Medical condition, medication or sleep\-related movement disorder that may be causative of the insomnia symptoms,
•3\.Shift\-worker working hours between 10pm and 4am,
•4\.History of major psychiatric disorder in the past 12 months, such as severe depression, anxiety or other psychopathologic condition based on self\-report or depression scores on the DASS21 greater than or equal to 21 or anxiety scores on the DASS21 greater than or equal to 15, except clinically managed mild depression,
•5\. History of suicide attempt, current suicide ideation or self\-harm,
•6\. History of hypersensitivity or severe adverse reaction including but not limited to anaphylaxis to any ingredients in SVT\-4A1011,
•7\. Skin sensitivity to adhesive or tape,
•8\. Use of any investigational drug and/or device within 4 weeks of screening or intent to use within the duration of the study,
•9\. History of any infection requiring hospitalisation, parental antimicrobial therapy, or as otherwise judged clinically significant, within the 3 months prior to screening,
•10\.Any prior history of septicaemia or bacteraemia,