Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625307
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
A Research Study on the Effects of NNC0537-1482 in Healthy Individuals When Injected Under the Skin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A First-in-human Randomised Placebo-controlled and Double-blinded Single Ascending Dose Study Investigating the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Subcutaneous Administrations of NNC0537-1482 in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is testing a new medicine to potentially treat people with heart failure The main purpose of the study is to see if the new study medicine is safe and how it works in the body It is the first time NNC0537-1482 the new study medicine is tested in humans and will be tested in healthy individuals men and postmenopausal women Participant will either get NNC0537-1482 or placebo a dummy medicine without any active ingredients Which treatment the participant get is decided by chance and the participant will only get either the study medicine or placebo on one occasion It will be injected under the skin of the stomach by the study staff and the number of injections will depend on the cohort participant is assigned to NNC0537-1482 cannot be prescribed by doctors The study consists of 6 cohorts groups with 6 different dosing levels The study will last for about 9 months Participation in the study will last up to 42 days depending on the cohort participant are assigned to with an additional screening period that can be up to 28 days Participant will have up to 10 visits to the clinic during the study period However the total number of visits depend on which cohort participant is assigned to
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None