Investigation of safety, tolerability and PK of single sc injections of NNC0581-0001
Research type
Research Study
Full title
A first human dose study investigating safety, tolerability, and pharmacokinetics of single subcutaneous injections of NNC0581-0001 in healthy adults
IRAS ID
1006044
Contact name
Jesper Clausen
Contact email
Sponsor organisation
Novo Nordisk
Eudract number
2022-001359-18
Clinicaltrials.gov Identifier
Research summary
This is a first-in-human (FIH), Phase I, single-centre trial in 48 healthy male and female subjects of non-childbearing potential aged 18 to 55 years. The main purpose of the trial is to see how safe the trial medicine NNC0581-0001 is and how well the body tolerates the trial medicine after single doses, injected under the skin (subcutaneously, SC). The trial will also investigate how the trial medicine is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) (overall referred to as pharmacokinetics [PK]).
The trial consists of a Screening Period of 28 days, 1 dosing day and a Follow-up Period of 52 weeks with 17 ambulatory visits and phone calls for safety follow-up. Participants will be required to stay in the Clinical Trial Unit from the day before dosing until at least 72 hours after dosing.
Single rising doses (10, 30, 90, 250, 600 and 1000 mg SC) will be administered to 6 separate cohorts of 8 participants each in a double-blind, randomised, placebo-controlled trial design. Per cohort, 6 participants will receive NNC0581-0001 and 2 participants will receive placebo. The next higher doses will only be administered if the previous dose level was found to be safe. Doses may also be adapted depending on safety results of the previous dose level and up to 2 additional cohorts may be added.
NNC0581 0001 is a small interfering ribonucleic acid (siRNA) that is being developed by Novo Nordisk to decrease the severity of non-alcoholic fatty liver disease and protect against development of cirrhosis (liver scarring).
As this is the first trial with NNC0581-0001 in humans, no human safety data is available yet. Based on the nonclinical safety data, no clinically relevant undesirable effects are expected.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0565
Date of REC Opinion
17 Nov 2022
REC opinion
Further Information Favourable Opinion