Safety and levels of TP-6076 in the lung; version 1
Research type
Research Study
Full title
A Phase 1, Open-Label, Randomized, Pharmacokinetic and Safety Study To Assess Bronchopulmonary Disposition Of Intravenous TP-6076 In Healthy Men And Women (HMR: 18-017)
IRAS ID
254138
Contact name
Jeremy Dennison
Contact email
Sponsor organisation
Tetraphase Pharmaceutical Inc.
Eudract number
2000-123456-78
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
TP-6076 (the study medicine) is a new antibiotic for treating serious and life threatening bacterial infections. Antibiotics work by killing bacteria or preventing them from reproducing and spreading. Some types of bacteria may infect the lungs and can cause a serious illness, such as pneumonia. There are existing antibiotics available to treat bacterial infections, but not all can reach the lung. Also, some types of bacteria are becoming resistant to many different types of antibiotics. We hope that the study medicine will reach the lungs, and will work by killing bacteria that are resistant to other types of antibiotics.
We’re doing this study to find out how much of the study medicine gets into the lungs, its blood levels and if it has any side effects after repeated doses. In particular, we’ll do a procedure called a bronchoscopy, to look into the lungs and take samples of lung fluid.
We’ll give up to 25 healthy men and women, aged 18–50 years doses of the study medicine by slow injection into a vein once each day for 4 days.
Participants will have a screening visit within 4 weeks of starting the study. They’ll have 1 outpatient visit, and a stay on the ward for 6 days and 5 nights, and take up to 3 weeks to finish the study.
A pharmaceutical company (Tetraphase Pharmaceuticals, Inc.) is funding the study.
The study will take place at 1 centre in London.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
18/EE/0324
Date of REC Opinion
9 Nov 2018
REC opinion
Further Information Favourable Opinion