17-0301 A Phase 1 Study of Single Ascending Doses of NGM217 in Adults
Research type
Research Study
Full title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of NGM217 in Adults with Autoimmune Diabetes
IRAS ID
233895
Contact name
Publication of this data is currently deferred.
Contact email
Sponsor organisation
NGM Biopharmaceuticals
Eudract number
2017-003266-27
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study is a First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics (how the body absorbs and distributes the drug) , and Pharmacodynamics (the effect of the drug on the body) of a Single Dose of NGM217 in Adults with Autoimmune Diabetes. Autoimmune diabetes is where the body’s immune system attacks and kills off insulin producing cells. \n\nA UK Prospective Diabetes Study found that antibodies specific to Autoimmune Diabetes cases are found in between 6% and 10% of diabetes cases. Amongst people diagnosed with diabetes at an age younger than 35 years old, Autoimmune Diabetes may account for up to 25% of cases. \n\nThe study will also explore the relationship between the effects of the drug and some measurable substances in the body (“biomarkers”). Measuring these biomarkers will require collecting blood samples at various points in the study.\nApproximately 32 patients will take part in the study, over approximately 6 different hospital sites in the UK.\n\nThe study involves up to 11 visits. There will be a period of up to 14 days for screening, a 27 day run-in period, a single administration of NGM217 and a 71 day follow up period, for a total of up to 112 days per patient. \n
REC name
London - Central Research Ethics Committee
REC reference
17/LO/1623
Date of REC Opinion
2 Nov 2017
REC opinion
Further Information Favourable Opinion