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

NCT ID: NCT05127473

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-14

Study Completion Date

2022-05-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers - Haemophilia A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose level 1

All participants will receive a single dose of Mim8

Group Type EXPERIMENTAL

Mim8 B, 10 mg/mL

Intervention Type DRUG

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.

Mim8 B, placebo

Intervention Type DRUG

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

Dose level 2

All participants will receive a single dose of Mim8

Group Type EXPERIMENTAL

Mim8 B, 10 mg/mL

Intervention Type DRUG

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.

Dose level 3

All participants will receive a single dose of Mim8

Group Type EXPERIMENTAL

Mim8 B, 100 mg/mL

Intervention Type DRUG

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.

Mim8 B, placebo

Intervention Type DRUG

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

Dose level 4

All participants will receive a single dose of Mim8

Group Type EXPERIMENTAL

Mim8 B, 10 mg/mL

Intervention Type DRUG

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.

Dose level 5

All participants will receive a single dose of Mim8

Group Type EXPERIMENTAL

Mim8 B, 100 mg/mL

Intervention Type DRUG

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.

Mim8 B, placebo

Intervention Type DRUG

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

Dose level 6

All participants will receive a single dose of Mim8

Group Type EXPERIMENTAL

Mim8 B, 10 mg/mL

Intervention Type DRUG

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.

Dose level 7

All participants will receive a single dose of Mim8

Group Type EXPERIMENTAL

Mim8 B, 100 mg/mL

Intervention Type DRUG

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.

Dose level 8

All participants will receive a single dose of Mim8

Group Type EXPERIMENTAL

Mim8 B, 100 mg/mL

Intervention Type DRUG

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.

Mim8 B, placebo

Intervention Type DRUG

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

Dose level 9

All participants will receive a single dose of Mim8

Group Type EXPERIMENTAL

Mim8 B, 100 mg/mL

Intervention Type DRUG

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.

Mim8 B, placebo

Intervention Type DRUG

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

Dose level 10

All participants will receive a single dose of Mim8

Group Type EXPERIMENTAL

Mim8 B, 100 mg/mL

Intervention Type DRUG

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.

Dose level 11

All participants will receive a single dose of Mim8

Group Type EXPERIMENTAL

Mim8 B, 100 mg/mL

Intervention Type DRUG

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.

Mim8 B, placebo

Intervention Type DRUG

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

Dose level 12

All participants will receive a single dose of Mim8

Group Type EXPERIMENTAL

Mim8 B, 100 mg/mL

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Mim8 B, placebo

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

Intervention Type DRUG

Other Intervention Names

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NN0365-3769 NN0365-3769

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Mainz, , Germany

Site Status

Novo Nordisk Investigational Site

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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U1111-1266-4001

Identifier Type: OTHER

Identifier Source: secondary_id

2021-003182-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN7769-4882

Identifier Type: -

Identifier Source: org_study_id

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