A study to investigate the safety/PK of SPR720 in healthy volunteers
Research type
Research Study
Full title
A Two-part, Randomized, Double-blind, Placebo controlled, First-In-Human, Phase I Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 Following Administration of Single and Multiple Ascending Oral Doses in Healthy Volunteers.
IRAS ID
254659
Contact name
Annelize Koch
Contact email
Sponsor organisation
Spero Therapeutics Inc.
Eudract number
2018-003116-41
Duration of Study in the UK
0 years, 6 months, 8 days
Research summary
This is a 2 part study which will evaluate the safety and pharmacokinetics of a new investigational drug called SPR720. This drug is being developed as a single oral antibiotic treatment for the management and treatment of lung infections caused by nontuberculous mycobacterium (NTM).
These types of lung infections are prolonged and difficult to treat and currently there is no single therapy that is effective in the management of these conditions. Current treatment involves the use of multiple different antibiotics given over a period of up to 18 months.
The first part of the study will compare SPR720 to placebo when given as a single dose. Doses will be evaluated in an ascending manner in up to 8 cohorts in the first part of the study. One group within the first part of the study will also investigate the food effect of SPR720. Within each successive cohort the dose will be increased, provided it is considered acceptable to do so.
The second part of the study will compare SPR720 to placebo when given as multiple doses over a period of 7 days.The main purpose for this study is to evaluate the safety and pharmacokinetics (how the body handles the drug) of SPR720. This study will be conducted in up to 120 healthy male or females of non-child bearing potential (80 in the first part and 40 in the second part), at Simbec, a research facility located in Wales, UK.
REC name
Wales REC 1
REC reference
18/WA/0348
Date of REC Opinion
8 Nov 2018
REC opinion
Favourable Opinion