Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
name: Fortrea
First posted: 2024-05-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of all TEAEs
timeFrame: 7 days
Secondary outcomes:
measure: Radiation dosimetry and biodistribution of GEH200521 (18F) Injection after the GEH200520 Injection mass doses.
timeFrame: 7 days
measure: Optimal imaging window post-GEH200521 (18F) Injection after the GEH200520 Injection mass doses.
timeFrame: 7 days
measure: Mass dose of GEH200520 Injection followed by a fixed dose of GEH200521 (18F) Injection to achieve a diagnostic positron emission tomography (PET) image quality.
timeFrame: 7 days
measure: 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.
timeFrame: 7 days
measure: Pharmacokinetic property of Cmax of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection.
timeFrame: 7 days
measure: Pharmacokinetic property of clearance (CL) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection.
timeFrame: 7 days
measure: 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.
timeFrame: 7 days
measure: 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.
timeFrame: 7 days
measure: Collection of the incidence, severity, changes between visits for AEs/SAEs/AESIs.
timeFrame: 7 days
measure: Proportion of subjects with clinically significant abnormalities detected during physical examination status by system organs following administration of GEH200520 and GEH200521 (18F).
timeFrame: 7 days
measure: Proportion of subjects with clinically significant abnormalities detected for serum biochemistry test results following administration of GEH200520 and GEH200521 (18F).
timeFrame: 7 days
measure: Proportion of subjects with clinically significant abnormalities detected for haematology test results following administration of GEH200520 and GEH200521 (18F).
timeFrame: 7 days
measure: Proportion of subjects with clinically significant abnormalities detected for beats per minute following administration of GEH200520 and GEH200521 (18F).
timeFrame: 7 days
measure: Changes in systolic and diastolic blood pressure in mmHg following administration of GEH200520 and GEH200521 (18F).
timeFrame: 7 days
measure: Changes in temperature as degree F following administration of GEH200520 and GEH200521 (18F).
timeFrame: 7 days
measure: Proportion of subjects with clinically significant abnormalities detected during 12-lead electrocardiograms (ECGs) following administration of GEH200520 and GEH200521 (18F).
timeFrame: 7 days
measure: Incidence of treatment induced and treatment enhance anti drug antibody responses following administration of GEH200520 and GEH200521 (18F)
timeFrame: 7 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: GE Healthcare
name: Yaron Raiter
role: STUDY_DIRECTOR
References: