Study Assessing Safety,Tolerability, PK & PD of 2 Drugs for Infection
Research type
Research Study
Full title
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Doses of CMS and Zidovudine Administered Alone and Co-Administered in Healthy Subjects
IRAS ID
211441
Contact name
Dennis Molnar
Contact email
Sponsor organisation
Helperby Therapeutics
Eudract number
2016-002767-34
Duration of Study in the UK
0 years, 2 months, 12 days
Research summary
The Sponsor is developing a new drug by using two marketed products to help fight bacteria that are no longer killed by the antibiotics that are currently used. The purpose of the study is to investigate how safe and well tolerated colistimethate sodium and zidovudine are when given separately and also when given at the same time. \n\nColistimethate sodium (CMS) is a commercially available drug commonly used for the treatment of bacterial infections. Zidovudine is a drug that is used to kill some types of virus. It is thought that using zidovudine with the CMS will help kill bacteria that are difficult to kill using single antibiotics alone. \n\nThe study will consist of up to 4 groups involving up to 56 healthy male and female subjects between the ages of 18-50 years. Groups 2, 3 and 4 are optional and will be based upon safety results from the previous groups. A study visit will last up to 4 days with 3 overnight stays. Blood and urine samples will be collected from subjects at specific times throughout the study.\n\n\n
REC name
HSC REC B
REC reference
16/NI/0166
Date of REC Opinion
16 Aug 2016
REC opinion
Favourable Opinion