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

GE Healthcare22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 7 days

Secondary Outcomes

Radiation dosimetry and biodistribution of GEH200521 (18F) Injection after the GEH200520 Injection mass doses.

Time frame: 7 days

Optimal imaging window post-GEH200521 (18F) Injection after the GEH200520 Injection mass doses.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 7 days

Collection of the incidence, severity, changes between visits for AEs/SAEs/AESIs.

Time frame: 7 days

Proportion of subjects with clinically significant abnormalities detected during physical examination status by system organs following administration of GEH200520 and GEH200521 (18F).

Time frame: 7 days

Proportion of subjects with clinically significant abnormalities detected for serum biochemistry test results following administration of GEH200520 and GEH200521 (18F).

Time frame: 7 days

Proportion of subjects with clinically significant abnormalities detected for haematology test results following administration of GEH200520 and GEH200521 (18F).

Time frame: 7 days

Proportion of subjects with clinically significant abnormalities detected for beats per minute following administration of GEH200520 and GEH200521 (18F).

Time frame: 7 days

Changes in systolic and diastolic blood pressure in mmHg following administration of GEH200520 and GEH200521 (18F).

Time frame: 7 days

Changes in temperature as degree F following administration of GEH200520 and GEH200521 (18F).

Time frame: 7 days

Proportion of subjects with clinically significant abnormalities detected during 12-lead electrocardiograms (ECGs) following administration of GEH200520 and GEH200521 (18F).

Time frame: 7 days

Incidence of treatment induced and treatment enhance anti drug antibody responses following administration of GEH200520 and GEH200521 (18F)

Time frame: 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

Time frame: 13 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes