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NNC0560-0004 · 1 trial · 1 indication
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| Arm | Type | Description |
|---|---|---|
| NNC0560-0004 | EXPERIMENTAL | The study will be conducted in 3 parts. Participants will be randomized to receive NNC0560-0004 in Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD) No randomisation - only active treatment in Part C: Single dose |
| Placebo (NNC0560-0004) | PLACEBO_COMPARATOR | Participant will be randomized to receive placebo in: Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD) |
| Name | Type | Description |
|---|---|---|
| NNC0560-0004 | DRUG | NNC0560-0004, Oral administration (taken through the mouth) |
| Placebo (NNC0560-0004) | DRUG | Placebo matching NNC0560-0004, Oral administration (taken through the mouth) |
Key inclusion criteria: 1. Female, of non-childbearing potential, or male, both genders aged 18-55 years (both inclusive) at the time of signing informed consent. 2. Body Mass Index (BMI) between 18.5 and 29.9 kg/m\^2 (both inclusive) at screening. 3. Considered to be generally healthy based on the...
NNC0560-0004 is an investigational small molecule developed by Novo Nordisk A/S for a gastrointestinal therapeutic area. It has been studied in a single Phase 1 first-in-human trial in healthy adult volunteers. The specific disease indication being pursued has not been disclosed.
NNC0560-0004 is being developed by Novo Nordisk A/S, which trades on the New York Stock Exchange under the ticker NVO. The company sponsored the Phase 1 first-in-human study of the compound conducted in the United Kingdom.
NNC0560-0004 is in Phase 1 clinical development. Its only recorded trial, NCT06133270, was a Phase 1 first-in-human dose study that has been completed. The compound remains investigational and has not been approved by the FDA.
NNC0560-0004 has been evaluated in one clinical trial, NCT06133270, titled a first human dose study investigating safety and blood concentration of the study medicine after once daily oral dosing in healthy adults. The trial enrolled 51 participants in the United Kingdom and is completed.
The NCT06133270 trial was a randomized, double-blind, placebo-controlled Phase 1 study of once daily oral NNC0560-0004 in healthy adults aged 18 years and older. It enrolled 51 participants across all sexes in the United Kingdom and assessed safety and blood concentrations of the study medicine.