A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of Reformulated NNC0365-3769 (Mim8) in Healthy Male Participants

NN0365-3769 (Mim8) is a study medicine with the potential to prevent and reduce bleeding in people with haemophilia A (an inherited disorder in which blood does not coagulate properly).

This study will investigate if different doses of Mim8 are safe, and also check how Mim8 behaves in the body.

Twelve different doses will be tested. Participants will only get one of the doses. Which dose participants get is decided by chance. Participants will get a single injection under the skin of the belly by means of a syringe and a needle.

The study will last for about 17 - 21 weeks.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers - Haemophilia A
• Intervention / Treatment: Drug: Mim8 B, 10 mg/mL; Drug: Mim8 B, placebo; Drug: Mim8 B, 100 mg/mL

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 55116
    • Novo Nordisk Investigational Site
  • Neuss, Germany, 41460
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male, aged 18-55 years (both inclusive) at the time of signing informed consent
• Body mass index between 18.5 and 29.9 kg/m^2 (both inclusive)
• Body weight between 60.0 to 100.0 kg (both inclusive)
• 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:

• Increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis
• Any clinical signs or established diagnosis of venous or arterial thromboembolic disease
• Factor VIII activity greater than or equal to150% at screening

• Any of the thrombophilia markers listed below:

  • Protein C, protein S or antithrombin below the lower normal laboratory range
  • Factor II activity, activated protein C resistance, lupus anticoagulant, anti-cardiolipin antibody (IgG and IgM) or anti-β2 glycoprotein I antibody (IgG and IgM) outside the normal laboratory range at screening

Study Plan

How is the study designed?

Design Details

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

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose level 1; All participants will receive a single dose of Mim8	Drug: Mim8 B, 10 mg/mL; All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.; Other Names: NN0365-3769; Drug: Mim8 B, placebo; Placebo will be used to dilute the IMP to different Mim8 concentrations
Experimental: Dose level 2; All participants will receive a single dose of Mim8	Drug: Mim8 B, 10 mg/mL; All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.; Other Names: NN0365-3769
Experimental: Dose level 3; All participants will receive a single dose of Mim8	Drug: Mim8 B, placebo; Placebo will be used to dilute the IMP to different Mim8 concentrations; Drug: Mim8 B, 100 mg/mL; All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.; Other Names: NN0365-3769
Experimental: Dose level 4; All participants will receive a single dose of Mim8	Drug: Mim8 B, 10 mg/mL; All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.; Other Names: NN0365-3769
Experimental: Dose level 5; All participants will receive a single dose of Mim8	Drug: Mim8 B, placebo; Placebo will be used to dilute the IMP to different Mim8 concentrations; Drug: Mim8 B, 100 mg/mL; All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.; Other Names: NN0365-3769
Experimental: Dose level 6; All participants will receive a single dose of Mim8	Drug: Mim8 B, 10 mg/mL; All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.; Other Names: NN0365-3769
Experimental: Dose level 7; All participants will receive a single dose of Mim8	Drug: Mim8 B, 100 mg/mL; All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.; Other Names: NN0365-3769
Experimental: Dose level 8; All participants will receive a single dose of Mim8	Drug: Mim8 B, placebo; Placebo will be used to dilute the IMP to different Mim8 concentrations; Drug: Mim8 B, 100 mg/mL; All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.; Other Names: NN0365-3769
Experimental: Dose level 9; All participants will receive a single dose of Mim8	Drug: Mim8 B, placebo; Placebo will be used to dilute the IMP to different Mim8 concentrations; Drug: Mim8 B, 100 mg/mL; All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.; Other Names: NN0365-3769
Experimental: Dose level 10; All participants will receive a single dose of Mim8	Drug: Mim8 B, 100 mg/mL; All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.; Other Names: NN0365-3769
Experimental: Dose level 11; All participants will receive a single dose of Mim8	Drug: Mim8 B, placebo; Placebo will be used to dilute the IMP to different Mim8 concentrations; Drug: Mim8 B, 100 mg/mL; All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.; Other Names: NN0365-3769
Experimental: Dose level 12; All participants will receive a single dose of Mim8	Drug: Mim8 B, 100 mg/mL; All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.; Other Names: NN0365-3769

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment-emergent adverse events	Count	From time of dosing (day 1) to day 113

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of injection site reactions	Count	From time of dosing (day 1) to day 113
Cmax, SD: the maximum concentration of Mim8 after a single dose	messured in μg/mL	From time of dosing (day 1) to day 113
AUC0-inf, SD: the area under the Mim8 concentration-time curve from time 0 to infinity after a single dose	messured in μg*day/mL	From time of dosing (day 1) to day 113
t1/2, SD: the terminal half-life of Mim8 after a single dose	messured in days	From time of dosing (day 1) to day 113
tmax, SD: the time to maximum concentration of Mim8 after a single dose	messured in days	From time of dosing (day 1) to day 113
Change in activated partial thromboplastin time	messured in seconds	From baseline (day 1) to day 113

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Actual): May 14, 2022
• Study Completion (Actual): May 14, 2022

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID Numbers: NN7769-4882; U1111-1266-4001 (Other Identifier: World Health Organization (WHO)); 2021-003182-35 (EudraCT Number)

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