Safety, tolerability, PK and PD of SCO-094 in type 2 diabetic patients
Research type
Research Study
Full title
Randomized, placebo-controlled, double-blind, single-centre, Phase 1 trial to investigate tolerability, safety, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SCO-094 subcutaneously administered in patients with type 2 diabetes
IRAS ID
281940
Contact name
Jorg Taubel
Contact email
Sponsor organisation
Scohia Pharma, Inc.
Eudract number
2020-000999-37
Duration of Study in the UK
0 years, 6 months, 12 days
Research summary
This is a study of an experimental drug called SCO-094. SCO-094 is being developed by Scohia Pharma, Inc. as a treatment for type 2 diabetes. This is a first-in-human, phase I, randomised, placebo-controlled, double-blind single and multiple dose study. The aim is to evaluate the safety and tolerability of SCO-094 to patients with type 2 diabetes; as well as to assess the way SCO-094 affects the body and is effected by the body.
SCO-094 is a peptide molecule which acts on the same molecular target as two naturally occurring hormones called incretins. These hormones promote insulin secretion following a meal. Insulin reduces blood sugar and it is hoped that SCO-094 will prove to be a safe and efficient drug to improve blood sugar control in type 2 diabetics.
SCO-094 is administered as an injection to the fatty tissue just below the skin (subcutaneous). The trial will be performed in two parts:
Part 1: Single ascending dose of SCO-094 or placebo administered as a single dose on day 1.
Part 2: Multiple doses of SCO-094 or placebo administered once daily on days 1 to 5.In part 1 patients will be admitted to the unit on day -2, receive a single dose on day 1 and will be discharged on day 3 to return for a follow-up visit on day 14.
In part 2 patients will be admitted to the unit on day -2, receive once daily dosing on days 1 to 5 and will be discharged on day 6, to return for a follow-up visit on day 13.
REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/0577
Date of REC Opinion
8 Jun 2020
REC opinion
Favourable Opinion