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First received: April 23, 2024

Clinical Trial: 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

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Healthy Volunteers

Study Type: INTERVENTIONAL


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 Biodistribu

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…

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