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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
| Fortrea | INDUSTRY |
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This is a Phase 1, single-center, open-label, single-arm, dose-escalation positron emission tomography study to assess the safety and tolerability, immunogenicity, Pharmacokinetics, dosimetry, and biodistribution after GEH200521 (18F) Injection is co-administered with GEH200520 Injection in healthy volunteers.
The estimated study duration for each subject is approximately 28 days in part A and 34 days in part B.
The primary study objective is to evaluate the safety and tolerability of the IMPs, the selected mass doses of GEH200520 Injection co-administered with a fixed dose of GEH200521 (18F) Injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEH200520 Injection and GEH200521 (18F) Injection | Drug | Administration of GEH200520 Injection followed by GEH200521 (18F) Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all TEAEs | 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation dosimetry and biodistribution of GEH200521 (18F) Injection after the GEH200520 Injection mass doses. | 7 days | |
| Optimal imaging window post-GEH200521 (18F) Injection after the GEH200520 Injection mass doses. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaron Raiter | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| A non-radiolabeled GEH200520 - 12 mg or 15 mg | Experimental |
|
| 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 |
|
| Mass dose of GEH200520 Injection followed by a fixed dose of GEH200521 (18F) Injection to achieve a diagnostic positron emission tomography (PET) image quality. | 7 days |
| Pharmacokinetic property of the area under the curve (AUC) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection. | 7 days |
| Pharmacokinetic property of Cmax of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection. | 7 days |
| Pharmacokinetic property of clearance (CL) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection. | 7 days |
| Pharmacokinetic property volume of distribution (V) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection. | 7 days |
| To characterise the pharmacokinetic property of the elimination half-life (t1/2) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection. | 7 days |
| Collection of the incidence, severity, changes between visits for AEs/SAEs/AESIs. | 7 days |
| Proportion of subjects with clinically significant abnormalities detected during physical examination status by system organs following administration of GEH200520 and GEH200521 (18F). | 7 days |
| Proportion of subjects with clinically significant abnormalities detected for serum biochemistry test results following administration of GEH200520 and GEH200521 (18F). | 7 days |
| Proportion of subjects with clinically significant abnormalities detected for haematology test results following administration of GEH200520 and GEH200521 (18F). | 7 days |
| Proportion of subjects with clinically significant abnormalities detected for beats per minute following administration of GEH200520 and GEH200521 (18F). | 7 days |
| Changes in systolic and diastolic blood pressure in mmHg following administration of GEH200520 and GEH200521 (18F). | 7 days |
| Changes in temperature as degree F following administration of GEH200520 and GEH200521 (18F). | 7 days |
| Proportion of subjects with clinically significant abnormalities detected during 12-lead electrocardiograms (ECGs) following administration of GEH200520 and GEH200521 (18F). | 7 days |
| Incidence of treatment induced and treatment enhance anti drug antibody responses following administration of GEH200520 and GEH200521 (18F) | 7 days |
| Test-retest imaging reliability of GEH200521 (18F) Injection co-administered with the selected mass dose of GEH200520 Injection, when administered on 2 different days | 13 days |
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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