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Mim8 B,mL

Phase 1

Undisclosed | Small Molecules | Hematology |Novo Nordisk A/S|Trials Updated: Nov 1, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Mim8 B,mL clinical trials

Mim8 B,mL · 1 trial · 1 indication

Phase 1 1
NCT05127473A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy PeopleHealthy Volunteers - Haemophilia A
COMPLETED66 Analytics
PHASE1COMPLETED
A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People
Healthy Volunteers - Haemophilia A
NCT0512747366
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Study Endpoints

Primary Endpoints

Number of treatment-emergent adverse events
From time of dosing (day 1) to day 113

Count

Secondary Endpoints

Number of injection site reactions
From time of dosing (day 1) to day 113
Cmax, SD: the maximum concentration of Mim8 after a single dose
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
From time of dosing (day 1) to day 113
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose level 1EXPERIMENTALAll participants will receive a single dose of Mim8
Dose level 2EXPERIMENTALAll participants will receive a single dose of Mim8
Dose level 3EXPERIMENTALAll participants will receive a single dose of Mim8
Dose level 4EXPERIMENTALAll participants will receive a single dose of Mim8
Dose level 5EXPERIMENTALAll participants will receive a single dose of Mim8
Dose level 6EXPERIMENTALAll participants will receive a single dose of Mim8
Dose level 7EXPERIMENTALAll participants will receive a single dose of Mim8
Dose level 8EXPERIMENTALAll participants will receive a single dose of Mim8
Dose level 9EXPERIMENTALAll participants will receive a single dose of Mim8
Dose level 10EXPERIMENTALAll participants will receive a single dose of Mim8
Dose level 11EXPERIMENTALAll participants will receive a single dose of Mim8
Dose level 12EXPERIMENTALAll participants will receive a single dose of Mim8

Interventions

NameTypeDescription
Mim8 B, 10 mg/mLDRUGAll 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, 100 mg/mLDRUGAll 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, placeboDRUGPlacebo will be used to dilute the IMP to different Mim8 concentrations
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites2

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 ...

Countries:Germany
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Frequently asked questions about Mim8 B,mL

What is Mim8 B,mL?

Mim8 B,mL is an investigational small molecule developed by Novo Nordisk A/S for hematology. It has been studied in a Phase 1 trial in healthy male volunteers in Germany. The specific indication being pursued has not been disclosed, and the compound remains in clinical development rather than approved for any use.

Who makes Mim8 B,mL?

Mim8 B,mL is being developed by Novo Nordisk A/S, which trades under the ticker NVO. The company sponsored the Phase 1 research study of the compound in healthy volunteers. Novo Nordisk is the sole developer named for this asset.

What phase is Mim8 B,mL in?

Mim8 B,mL is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. Because only early-stage testing has been conducted, Mim8 B,mL is investigational and has not been approved by the FDA or any other regulator.

What clinical trials is Mim8 B,mL in?

Mim8 B,mL has been evaluated in one completed Phase 1 trial, NCT05127473, titled a research study of how NNC0365-3769 (Mim8) works in the body of healthy people. The trial enrolled 66 participants in Germany, was randomized, double-blind, and controlled, and included healthy male volunteers aged 18 and older.

Is Mim8 B,mL the same as Mim8 B?

Yes. Mim8 B,mL is also known as Mim8 B and 10 mg/mL. These names refer to the same investigational compound from Novo Nordisk A/S, which was studied under the code NNC0365-3769 in the Phase 1 trial NCT05127473. Searches for any of these names point to the same asset.

What is Mim8 B,mL used for?

Mim8 B,mL is being studied in the hematology therapeutic area, and its Phase 1 trial enrolled healthy volunteers in a hemophilia A context. The specific indication the developer intends to pursue has not been disclosed. It is an investigational small molecule and is not approved for any indication.

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