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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment66
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05127473A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy PeoplePHASE1 COMPLETED 66 — — Jul 14, 2021May 14, 2022Nov 1, 20232 Germany
Unlock Drug Trial Details
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 — 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