Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GEH200520 and GEH200521 · 1 trial · 1 indication
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 ...
GEH200520 and GEH200521 are investigational small molecules being studied in healthy volunteers. They are part of a Phase 1 positron emission tomography study to assess safety, pharmacokinetics, dosimetry, and biodistribution. The study involves co-administering GEH200521 (18F) Injection with GEH200520 Injection. The drug is not approved and remains in clinical development.
GEH200520 and GEH200521 are being developed by GE HealthCare Technologies Inc., traded on the New York Stock Exchange under the ticker GEHC. The company is conducting a Phase 1 clinical trial of these investigational agents in healthy volunteers in the United States.
GEH200520 and GEH200521 are in Phase 1 clinical development. The Phase 1 trial, NCT06398730, is a dose-escalation positron emission tomography study in healthy volunteers. The trial has been completed. These agents are investigational and have not been approved by regulatory authorities.
GEH200520 and GEH200521 are being studied in one completed Phase 1 clinical trial, NCT06398730. This trial enrolled 22 healthy volunteers in the United States and assessed the safety, pharmacokinetics, dosimetry, and biodistribution of GEH200521 (18F) Injection co-administered with GEH200520 Injection.
Yes, GEH200520 and GEH200521 are also known as GEH200520 Injection / GEH200521 (18F) Injection - Part A, and GEH200520/ GEH200521- Part A. These alternative names refer to the same investigational agents being studied in the Phase 1 clinical trial.