Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGGEH200520 Injection and GEH200521 (18F) Injection
Administration of GEH200520 Injection followed by GEH200521 (18F) Injection
DIAGNOSTIC_TESTStatic - PET/CT scan
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
Sponsors
GE Healthcare
PPD Development, LP
Fortrea
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 mass index (BMI) ≥18 and ≤35 kg/m2. * The subject has no history of chronic medical illness or symptoms of active illness per Investigator's assessment. * The subject has no clinically significant deviation from normal ranges in physical examination, ECG, and clinical laboratory parameters. * Female and male contraception methods.
Exclusion criteria
* Subject is using prescribed and/or non-prescribed medication which in the Investigator's opinion might impact subject safety or the study results. * Subject has a known or suspected allergy to IMP and/or IMP ingredients. * Subject has had a surgery within 8 weeks prior to enrollment or a surgery is scheduled during the study. * Subject has been enrolled in this or another interventional clinical study within the 30 days before screening for this study or is actively participating in another clinical study with IMP(s). * Subject has been enrolled in another clinical study with radiation or exposed to radiation due to medical practice, which in the Investigator's opinion might impact subject safety or the study results. * Subject is pregnant, planning to become pregnant, or is lactating. * Creatinine and liver function laboratory values higher than 1.5x upper limit ranges per local site clinical practice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all TEAEs | 7 days | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 during physical examination status by system organs following administration of GEH200520 and GEH200521 (18F). | 7 days |
| 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 |
| 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 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 |
| Proportion of subjects with clinically significant abnormalities detected for serum biochemistry test results 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 |
Countries
United States
Contacts
STUDY_DIRECTORYaron Raiter
GE Healthcare
Outcome results
None listed