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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05569278 | Safety and Pharmacokinetics of GEH200486 in Healthy Volunteers | PHASE1 | COMPLETED | 15 | — | — | Aug 22, 2022 | Nov 29, 2022 | Jul 6, 2023 | 1 | Norway |
In this context, baseline is defined as the pre-treatment assessment at the screening visit. The occurrence of post injection values outside of normal limits and changes from baseline will be summarized.
In this context, baseline is defined as the pre-treatment assessment at the screening visit. The occurrence of post injection values outside of normal limits and changes from baseline will be summarized.
In this context, baseline is defined as the pre-treatment assessment at the screening visit. The occurrence of post injection values outside of normal limits and changes from baseline will be summarized.
| Arm | Type | Description |
|---|---|---|
| GEH200486 Cohort 1 | EXPERIMENTAL | Participants will receive 0.05 mmol/kg of GE200486 0.5 M injection |
| GEH200486 Cohort 2 | EXPERIMENTAL | Participants will receive 0.1 mmol/kg of GE200486 0.5 M injection |
| GEH200486 Cohort 3 | EXPERIMENTAL | Participants will receive 0.2 mmol/kg of GE200486 0.5 M injection |
| GEH200486 Cohort 4 | EXPERIMENTAL | Participants will receive 0.3 mmol/kg of GE200486 0.5 M injection |
| Name | Type | Description |
|---|---|---|
| GE200486 0.5M Injection | DRUG | Single administration by intravenous (IV) hand injection without dilution, followed by a 5mL saline flush |
Inclusion Criteria: * The subject is between 18 to 55 years of age * The subject has no currently active significant medical illness or history of chronic medical illness. * The subject has no clinically significant deviation from normal ranges in physical examination, ECG, and clinical laboratory ...