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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06398730 | A Phase 1, Dose-Escalation, Positron Emission Tomography Study to Assess the Safety, Pharmacokinetics, Dosimetry and Biodistribution of GEH200521 (18F) Injection Co-Administered With GEH200520 Injection in Healthy Volunteers | PHASE1 | COMPLETED | 22 | — | — | Jul 2, 2024 | Feb 23, 2026 | Mar 6, 2026 | 1 | United States |
Incidence of all grading of TEAEs per National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 based on the causality to the IMPs.
| Arm | Type | Description |
|---|---|---|
| A non-radiolabeled GEH200520 - 1 mg | EXPERIMENTAL | - |
| A non-radiolabeled GEH200520 - 2 mg | EXPERIMENTAL | - |
| A non-radiolabeled GEH200520 - 4 mg | EXPERIMENTAL | - |
| A non-radiolabeled GEH200520 - 6 mg | EXPERIMENTAL | - |
| A non-radiolabeled GEH200520 - 8 mg | EXPERIMENTAL | - |
| A non-radiolabeled GEH200520 - 10 mg | EXPERIMENTAL | - |
| A non-radiolabeled GEH200520 - 12 mg or 15 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GEH200520 Injection and GEH200521 (18F) Injection | DRUG | Administration of GEH200520 Injection followed by GEH200521 (18F) Injection |
| Static - PET/CT scan | DIAGNOSTIC_TEST | Repeat whole body static scan starting 3 minutes after injection followed by a single whole body static scan at 2 to 3 hours after injection and 4 to 5 hours after injection |
Inclusion Criteria: * The subject is able and willing to comply with all study procedures as described in the protocol, and has read, signed, and dated an informed consent form prior to any study procedures being performed. * The subject is male or female ≥18 years of age. * The subject has a body ...