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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01087645 | A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects | PHASE1 | COMPLETED | 70 | — | — | Mar 12, 2010 | Sep 16, 2010 | Feb 28, 2017 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Trial part 1 | EXPERIMENTAL | - |
| Trial part 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NN9925 (oral) | DRUG | Subjects will be randomised to receive a single dose of NN9925, at escalating dose levels. Progression to next dose will be based on safety evaluation |
| NN9925 (i.v.) | DRUG | As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit |
| placebo | DRUG | Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels |
Inclusion Criteria: * Male subjects with good general health as judged by the physician * Body weight of 65-95 kg (both inclusive) * Body Mass Index (BMI) of 18.5-27.5 kg/m2 (both inclusive) Exclusion Criteria: * Known or suspected allergy to trial product or related products * Acute infection or...