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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers - Haemophilia A

Treatments: Drug: Mim8 B, placebo; Drug: Mim8 B, 100 mg/mL; Drug: Mim8 B, 10 mg/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT05127473

2021-003182-35 (EudraCT Number)

U1111-1266-4001 (Other Identifier)

NN7769-4882

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 12 patient groups

Dose level 1

Experimental group

Description:

All participants will receive a single dose of Mim8

Treatment:

Drug: Mim8 B, 10 mg/mL

Drug: Mim8 B, placebo

Dose level 2

Experimental group

Description:

All participants will receive a single dose of Mim8

Treatment:

Drug: Mim8 B, 10 mg/mL

Dose level 3

Experimental group

Description:

All participants will receive a single dose of Mim8

Treatment:

Drug: Mim8 B, placebo

Drug: Mim8 B, 100 mg/mL

Dose level 4

Experimental group

Description:

All participants will receive a single dose of Mim8

Treatment:

Drug: Mim8 B, 10 mg/mL

Dose level 5

Experimental group

Description:

All participants will receive a single dose of Mim8

Treatment:

Drug: Mim8 B, placebo

Drug: Mim8 B, 100 mg/mL

Dose level 6

Experimental group

Description:

All participants will receive a single dose of Mim8

Treatment:

Drug: Mim8 B, 10 mg/mL

Dose level 7

Experimental group

Description:

All participants will receive a single dose of Mim8

Treatment:

Drug: Mim8 B, 100 mg/mL

Dose level 8

Experimental group

Description:

All participants will receive a single dose of Mim8

Treatment:

Drug: Mim8 B, placebo

Drug: Mim8 B, 100 mg/mL

Dose level 9

Experimental group

Description:

All participants will receive a single dose of Mim8

Treatment:

Drug: Mim8 B, placebo

Drug: Mim8 B, 100 mg/mL

Dose level 10

Experimental group

Description:

All participants will receive a single dose of Mim8

Treatment:

Drug: Mim8 B, 100 mg/mL

Dose level 11

Experimental group

Description:

All participants will receive a single dose of Mim8

Treatment:

Drug: Mim8 B, placebo

Drug: Mim8 B, 100 mg/mL

Dose level 12

Experimental group

Description:

All participants will receive a single dose of Mim8

Treatment:

Drug: Mim8 B, 100 mg/mL