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

Primary Purpose

Healthy Volunteers - Haemophilia A

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Mim8 B, 10 mg/mL

Mim8 B, 100 mg/mL

Mim8 B, placebo

About this trial

This is an interventional treatment trial for Healthy Volunteers - Haemophilia A

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Novo Nordisk Investigational Site
Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Arm Label

Dose level 1

Dose level 2

Dose level 3

Dose level 4

Dose level 5

Dose level 6

Dose level 7

Dose level 8

Dose level 9

Dose level 10

Dose level 11

Dose level 12

Arm Description

All participants will receive a single dose of Mim8

Outcomes

Primary Outcome Measures

Number of treatment-emergent adverse events

Count

Secondary Outcome Measures

Number of injection site reactions

Count

Cmax, SD: the maximum concentration of Mim8 after a single dose

messured in μg/mL

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

t1/2, SD: the terminal half-life of Mim8 after a single dose

messured in days

tmax, SD: the time to maximum concentration of Mim8 after a single dose

messured in days

Change in activated partial thromboplastin time

messured in seconds

Full Information

NCT ID

NCT05127473

First Posted

November 9, 2021

Last Updated

November 8, 2022

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT05127473

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

July 14, 2021 (Actual)

Primary Completion Date

May 14, 2022 (Actual)

Study Completion Date

May 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers - Haemophilia A

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose level 1

Arm Type

Experimental

Arm Description

All participants will receive a single dose of Mim8

Arm Title

Dose level 2

Arm Type

Experimental

Arm Description

All participants will receive a single dose of Mim8

Arm Title

Dose level 3

Arm Type

Experimental

Arm Description

All participants will receive a single dose of Mim8

Arm Title

Dose level 4

Arm Type

Experimental

Arm Description

All participants will receive a single dose of Mim8

Arm Title

Dose level 5

Arm Type

Experimental

Arm Description

All participants will receive a single dose of Mim8

Arm Title

Dose level 6

Arm Type

Experimental

Arm Description

All participants will receive a single dose of Mim8

Arm Title

Dose level 7

Arm Type

Experimental

Arm Description

All participants will receive a single dose of Mim8

Arm Title

Dose level 8

Arm Type

Experimental

Arm Description

All participants will receive a single dose of Mim8

Arm Title

Dose level 9

Arm Type

Experimental

Arm Description

All participants will receive a single dose of Mim8

Arm Title

Dose level 10

Arm Type

Experimental

Arm Description

All participants will receive a single dose of Mim8

Arm Title

Dose level 11

Arm Type

Experimental

Arm Description

All participants will receive a single dose of Mim8

Arm Title

Dose level 12

Arm Type

Experimental

Arm Description

All participants will receive a single dose of Mim8

Intervention Type

Drug

Intervention Name(s)

Mim8 B, 10 mg/mL

Other Intervention Name(s)

NN0365-3769

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Mim8 B, 100 mg/mL

Other Intervention Name(s)

NN0365-3769

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Mim8 B, placebo

Intervention Description

Placebo will be used to dilute the IMP to different Mim8 concentrations

Primary Outcome Measure Information:

Title

Number of treatment-emergent adverse events

Description

Count

Time Frame

From time of dosing (day 1) to day 113

Secondary Outcome Measure Information:

Title

Number of injection site reactions

Description

Count

Time Frame

From time of dosing (day 1) to day 113

Title

Cmax, SD: the maximum concentration of Mim8 after a single dose

Description

messured in μg/mL

Time Frame

From time of dosing (day 1) to day 113

Title

AUC0-inf, SD: the area under the Mim8 concentration-time curve from time 0 to infinity after a single dose

Description

messured in μg*day/mL

Time Frame

From time of dosing (day 1) to day 113

Title

t1/2, SD: the terminal half-life of Mim8 after a single dose

Description

messured in days

Time Frame

From time of dosing (day 1) to day 113

Title

tmax, SD: the time to maximum concentration of Mim8 after a single dose

Description

messured in days

Time Frame

From time of dosing (day 1) to day 113

Title

Change in activated partial thromboplastin time

Description

messured in seconds

Time Frame

From baseline (day 1) to day 113

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Transparency (dept. 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Mainz

ZIP/Postal Code

55116

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

IPD Sharing URL

http://novonordisk-trials.com

Learn more about this trial

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

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