Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03444467 | First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People. | PHASE1 | COMPLETED | 36 | — | — | Feb 5, 2018 | May 24, 2018 | Sep 5, 2018 | 1 | Germany |
Count of events
| Arm | Type | Description |
|---|---|---|
| NNC9204-1513 | EXPERIMENTAL | Participants will receive increasing doses of NNC9204-1513. |
| Glucagon | ACTIVE_COMPARATOR | Participants will receive a single fixed dose of glucagon. |
| Name | Type | Description |
|---|---|---|
| NNC9204-1513 | DRUG | Participants will receive NNC9204-1513 subcutaneous (s.c., in to a skin fold on the stomach) injection as single increasing doses of 0.01 mg, 0.04 mg, 0.10 mg, 0.25 mg, 0.50 mg, 1.0 mg or 2.0 mg. Each participant will only be given one dose. Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group. |
| Glucagon | DRUG | Participants will receive single dose of 1 mg glucagon s.c. injection. |
| Placebo | DRUG | Participants will receive single dose of placebo (for double dummy injections). |
Inclusion Criteria: * Male, aged 18 -55 years (both inclusive), at the time of signing informed consent * Body mass index (BMI) between 18.5 and 28.0 kg/sqm (both inclusive) * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG ...