Clinical trial NCT05624580: A Study to Look at Safety and Tolerability of NNC0582-0001, How it is Transported Throughout the Body and How it Works in Healthy Adults
Official title: Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injections of NNC0582-0001 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-11-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized, double-blind, sequential-group, placebo-controlled study with six sequential single dose cohorts with ascending dose levels in healthy adult participants. This study will assess the safety, tolerability, the pharmacokinetics from single subcutaneous administrations of NNC0582-0001 and explores the pharmacodynamics in healthy participants. Participants will be randomized in a 3:1 ratio to receive a fixed single dose (1-day) of NNC0582 0001 or placebo by injections under the skin. Participants will be followed up for 52 weeks post dose.


Eligibility criteria: Inclusion Criteria:

* Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body Mass Index (BMI) from 20.0 to 30.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimoles per mole \[mmol/mol\]) at screening.
* Any of the below laboratory safety parameters at screening outside normal range, see laboratory provided reference ranges for specific values (re-screening or re-sampling is NOT allowed if the participant has failed one of the exclusion criteria related to laboratory parameters):
* Alanine aminotransferase (ALT)
* Aspartate aminotransferase (AST)
* Bilirubin
* Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73m\^2 (mL/min/1.73m\^2)

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From dosing (Day 1) until End of Study visit (Week 52)
Secondary outcomes:
measure: AUC0-∞: The area under the NNC0582-0001 plasma concentration-time curve from time zero to infinity after a single dose.
timeFrame: From dosing (Day 1) to 168 hours after dosing
measure: Cmax: The maximum concentration of NNC0582-0001 in plasma
timeFrame: From dosing (Day 1) to 168 hours after dosing
measure: tmax: The time from dose administration to maximum plasma concentration of NNC0582-0001
timeFrame: From dosing (Day 1) to 168 hours after dosing
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Clinical Trials Unit / Center for Medical Research
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: