LY3016859 – first doses in humans; version 1

• Research type

  Research Study

• Full title

  Study of the Safety, Tolerability and Pharmacokinetics of LY3016859 after Single Intravenous and Subcutaneous Dosing in Healthy Volunteers. (HMR code: 12-004)

• IRAS ID

  100589

• Contact name

  Malcolm Boyce

• Sponsor organisation

  Chorus LRL, Eli Lilly and Company Ltd

• Eudract number

  2011-005596-17

• ISRCTN Number

  ISRCTN

• Research summary

  The study medicine (LY3016859) is an experimental treatment for diabetic kidney disease. People with diabetes can have long-term health problems, including kidney damage. Currently available medicines can help to prevent further kidney damage by controlling blood pressure, but don??t treat the cause of the damage. We hope that the study medicine, a monoclonal antibody, will prevent kidney damage in patients with diabetes, by blocking 2 substances produced by the body, called TGF-alpha and epiregulin. We'll give up to 56 healthy men and women, aged 18??65 years, single doses of LY3016859 by injection into a vein or injection under the skin. LY3016859 has never been given to humans before, so We'll start with a small dose, and increase the dose as the study progresses. We aim to find out its side effects and blood levels, and its effects on blood and urine levels of TGF-alpha and epiregulin. We'll also check whether participants make antibodies to LY3016859. If participants consent, we may also study how their genes (pieces of DNA) affect how the body responds to or handles LY3016859. Participants will take up to 12 weeks to finish the study. They??ll stay on the ward for 2 nights, and make up to 9 outpatient visits. A pharmaceutical company (Chorus, Lilly Research Laboratories, Eli Lilly and Company) is funding the study. The study will take place at 1 centre in London. We'll recruit healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/0311

• Date of REC Opinion

  7 Mar 2012

• REC opinion

  Favourable Opinion