A Research Study of a New Medicine (NNC0650-0013) in Healthy Men

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Subcutaneous Single Ascending Doses of NNC0650-0013 in Healthy Male Participants

This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a "dummy medicine" without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: NNC0650-0013 A; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Recruiting
    • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male.
• Age 18-55 years (both inclusive) at the time of signing the informed consent.
• Body mass index between 24.0 and 29.9 kilogram per meter square (kg/m^2) (both inclusive) at screening.
• Considered to be otherwise 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, unwillingness or inability, which, in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
• Glycated haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole (mmol/mol)) at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC0650-0013: Subcutaneous dose; Participants will receive NNC0650-0013 subcutaneously in an ascending dose manner.	Drug: NNC0650-0013 A; NNC0650-0013 will be administered subcutaneously or intravenously.
Placebo Comparator: Placebo; Participants will receive matching placebo to NNC0650-0013 subcutaneously.	Drug: Placebo; Subcutaneous administration.
Experimental: NNC0650-0013: Intravenous dose; Participants will receive NNC0650-0013 in an ascending dose manner intravenously.	Drug: NNC0650-0013 A; NNC0650-0013 will be administered subcutaneously or intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
S.C. Cohort: Number of treatment emergent adverse events (TEAEs)	Measured as number of events.	From time of dosing (day 1) until completion of the follow-up visit (day 75)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
S.C. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose	Measured as hours nanomoles per liter (h*nmol/L).	From pre-dose (day 1) until completion of the follow up visit (day 75)
S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose	Measured as nanomoles per liter (nmol/L).	From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose	Measured as h*nmol/L.	From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. Cohort: Cmax,0013,SD: Maximum observed plasma concentration of NNC0650-0013 after a single dose	Measured as nanomoles per liter (nmol/L).	From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031plasma concentration time curve from time 0 to infinity after a single dose	Measured as h*nmol/L.	From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose	Measured as nanomoles per liter (nmol/L).	From pre-dose (day 1) until completion of the follow-up visit (day 75)
I.V. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration-time curve from time 0 to infinity after a single dose	Measured as h*nmol/L.	From pre-dose (day 1) until completion of the follow-up visit (day 75)
I.V. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose	Measured as h*nmol/L.	From pre-dose (day 1) until completion of the follow-up visit (day 75)
I.V. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031 plasma concentration-time curve from time 0 to infinity after a single dose	Measured as h*nmol/L.	From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. and I.V. Cohort: AUC0-∞,0013,SD/dose: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose divided by the dose administered	Measured as hours nanomoles per milligram (h*nmol/mg).	From pre-dose (day1) until completion of the follow-up visit (day 75)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency' (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Estimated): March 22, 2025
• Study Completion (Estimated): March 22, 2025

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NN9650-5027; 2023-506134-79 (Other Identifier: European Medical Agency (EMA)); U1111-1291-7535 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No