Recent Updates
Recently added Catalysts

Mim8 B, mL

Phase 1

Healthy Volunteers - Haemophilia A | Small molecule | Hematology |Novo Nordisk A/S|Last Updated: Nov 1, 2023

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Mim8 B, mL

What is Mim8 B,mL used for?

Mim8 B,mL is an investigational small molecule being studied for use in healthy volunteers and in people with Haemophilia A. It is being developed by Novo Nordisk A/S (NVO) as a potential treatment within the hematology therapeutic area. The drug is currently in Phase 1 clinical development.

Who makes Mim8 B,mL?

Mim8 B,mL is being developed by Novo Nordisk A/S, a biopharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical research to evaluate the drug's effects in healthy volunteers and in individuals with Haemophilia A.

What phase is Mim8 B,mL in?

Mim8 B,mL is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for its safety and how it works in the body.

What clinical trials is Mim8 B,mL in?

Mim8 B,mL has been studied in one completed Phase 1 clinical trial with the identifier NCT05127473. This trial, titled 'A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People,' enrolled 66 male participants aged 18 years and older in Germany.

Is Mim8 B,mL the same as NNC0365-3769?

Yes, Mim8 B,mL is also known as NNC0365-3769. In clinical trial NCT05127473, the drug is referred to as NNC0365-3769 (Mim8), indicating that these names refer to the same investigational medicine being developed by Novo Nordisk.

Was the Mim8 B,mL clinical trial randomized and controlled?

Yes, the Phase 1 clinical trial for Mim8 B,mL (NCT05127473) was randomized, double-blind, and controlled. The study enrolled 66 healthy male volunteers and was conducted in Germany. The trial has been completed, and no active trials for this drug are currently listed.