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

Healthy Volunteers Clinical Trial

Official title:

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 Following GEH200521 (18F) Injection Co-Administered With GEH200520 Injection in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06398730
• Other study ID #: GE-269-004
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: GE Healthcare
• Contact: Yaron Raiter, MD
• Phone: +31 (6) 21288463
• Email: Yaron.Raiter[@]gehealthcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• GEH200520 Injection and GEH200521 (18F) Injection
Administration of GEH200520 Injection followed by GEH200521 (18F) Injection

Diagnostic Test:
• Static - 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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
GE Healthcare	Fortrea, PPD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Radiation dosimetry and biodistribution of GEH200521 (18F) Injection after the GEH200520 Injection mass doses.		7 days
Secondary	Optimal imaging window post-GEH200521 (18F) Injection after the GEH200520 Injection mass doses.		7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Collection of the incidence, severity, changes between visits for AEs/SAEs/AESIs.		7 days
Secondary	Proportion of subjects with clinically significant abnormalities detected during physical examination status by system organs following administration of GEH200520 and GEH200521 (18F).		7 days
Secondary	Proportion of subjects with clinically significant abnormalities detected for serum biochemistry test results following administration of GEH200520 and GEH200521 (18F).		7 days
Secondary	Proportion of subjects with clinically significant abnormalities detected for haematology test results following administration of GEH200520 and GEH200521 (18F).		7 days
Secondary	Proportion of subjects with clinically significant abnormalities detected for beats per minute following administration of GEH200520 and GEH200521 (18F).		7 days
Secondary	Changes in systolic and diastolic blood pressure in mmHg following administration of GEH200520 and GEH200521 (18F).		7 days
Secondary	Changes in temperature as degree F following administration of GEH200520 and GEH200521 (18F).		7 days
Secondary	Proportion of subjects with clinically significant abnormalities detected during 12-lead electrocardiograms (ECGs) following administration of GEH200520 and GEH200521 (18F).		7 days
Secondary	Incidence of treatment induced and treatment enhance anti drug antibody responses following administration of GEH200520 and GEH200521 (18F)		7 days