Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mim8 B, mL · 1 trial · 1 indication
Count
| Arm | Type | Description |
|---|---|---|
| Dose level 1 | EXPERIMENTAL | All participants will receive a single dose of Mim8 |
| Dose level 2 | EXPERIMENTAL | All participants will receive a single dose of Mim8 |
| Dose level 3 | EXPERIMENTAL | All participants will receive a single dose of Mim8 |
| Dose level 4 | EXPERIMENTAL | All participants will receive a single dose of Mim8 |
| Dose level 5 | EXPERIMENTAL | All participants will receive a single dose of Mim8 |
| Dose level 6 | EXPERIMENTAL | All participants will receive a single dose of Mim8 |
| Dose level 7 | EXPERIMENTAL | All participants will receive a single dose of Mim8 |
| Dose level 8 | EXPERIMENTAL | All participants will receive a single dose of Mim8 |
| Dose level 9 | EXPERIMENTAL | All participants will receive a single dose of Mim8 |
| Dose level 10 | EXPERIMENTAL | All participants will receive a single dose of Mim8 |
| Dose level 11 | EXPERIMENTAL | All participants will receive a single dose of Mim8 |
| Dose level 12 | EXPERIMENTAL | All participants will receive a single dose of Mim8 |
| Name | Type | Description |
|---|---|---|
| Mim8 B, 10 mg/mL | 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, 100 mg/mL | 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 | DRUG | Placebo will be used to dilute the IMP to different Mim8 concentrations |
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 ...
Mim8 B,mL is an investigational small molecule medicine developed by Novo Nordisk A/S for hemophilia A. It has been studied in healthy adult male volunteers rather than in patients with the bleeding disorder. The program is in Phase 1 clinical development, and the single completed trial enrolled 66 participants in Germany.
Mim8 B,mL is being developed for hemophilia A, a bleeding disorder. The completed Phase 1 study was conducted in healthy volunteers rather than in people with hemophilia A, so the work to date has focused on early study in healthy participants. It is not an approved treatment.
Mim8 B,mL is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor behind the Phase 1 program for this small molecule candidate in hemophilia A.
Mim8 B,mL is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The program has not advanced beyond early-stage testing, and Mim8 B,mL is investigational rather than an approved medicine.
Mim8 B,mL has been studied in one completed Phase 1 trial, NCT05127473, titled a research study of how NNC0365-3769 (Mim8) works in the body of healthy people. That randomized, double-blind, controlled trial enrolled 66 healthy male volunteers aged 18 years and older in Germany.
Yes. Mim8 B,mL is also known as Mim8 B and 10 mg/mL. These names refer to the same investigational Novo Nordisk compound studied under the code NNC0365-3769 in the Phase 1 trial NCT05127473, so searches using any of these names point to the same asset.