Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Insulin 320 · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Level 1-7 escalating doses | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Insulin 320 | DRUG | Subjects will be randomised to receive a single dose of Insulin 320 orally, at 7 escalating dose levels from 300 nmol to 21600 nmol. Progression to next dose level will be based on a safety evaluation. |
| insulin glargine | DRUG | As an open label active comparator, subjects will be randomised to receive a single dose of insulin glargine subcutaneously (s.c., under the skin), at all dose levels. The insulin glargine dose will be the same at all dose levels. |
| placebo | DRUG | Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels. |
Inclusion Criteria: * Male, aged 18-55 years (both inclusive) at the time of signing informed consent * Body mass index 18.5-28.0 kg/m\^2 (both inclusive) * Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |