Clinical Trials Logo

Clinical Trial Summary

The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL2107 with Keytruda® marketed in China and the United States in healthy male volunteers. Participants will receive a single injection of QL2107/ Keytruda® (China)/Keytruda® (US).Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the three groups.


Clinical Trial Description

This is a phase I,single center, randomized, double-blind and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of single injections of QL2107 or Keytruda® (China/US) in healthy volunteers. The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL2107 or Keytruda® (China/US) in healthy volunteers. Subjects would receive a single 100mg(4ml) of QL2107or Keytruda® (China/US)injection. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06173011
Study type Interventional
Source Qilu Pharmaceutical Co., Ltd.
Contact yanhua ding
Phone 0431-88782168
Email dingyanhua2003@126.com
Status Recruiting
Phase Phase 1
Start date December 12, 2023
Completion date July 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Active, not recruiting NCT05470283 - Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma Phase 1
Completed NCT05041920 - A Drug-drug Interaction Study of Famitinib Malate With a Proton Pump Inhibitor in Healthy Adult Subjects Phase 1
Recruiting NCT04430361 - the Efficacy and Safety of 5-HT3 Receptor Antagonist, Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy Phase 2
Not yet recruiting NCT05549557 - IMM40H Phase I Dose Escalation and Expansion Phase 1
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3
Completed NCT01946555 - Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain N/A
Terminated NCT01846429 - Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain Phase 1
Recruiting NCT01387971 - Using Impression Cytology to Observe the Cytological Changes of Ocular Surface Cells in Various Ocular Surface Disorders N/A
Recruiting NCT01093079 - Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes N/A
Recruiting NCT00690261 - The Impact of M1/M2 Tumor Associated Macrophage (TAM) Polarization on Cancer Progression and Prognosis Prediction N/A
Completed NCT00561795 - Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors Phase 2
Completed NCT00413322 - Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors Phase 1
Completed NCT00152659 - Developing Criteria for Cortical Resections
Completed NCT00777751 - Radiation Therapy and Cardiac Enzymes N/A
Not yet recruiting NCT06109896 - Clinical Stories and Psychological Experiences of Cancer Patients
Not yet recruiting NCT05879146 - Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study Phase 2
Recruiting NCT02810405 - Collection of Tissue Blocks or Slides From Patients With Cancer
Recruiting NCT01867268 - Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence Phase 2
Completed NCT01919710 - Safety and Efficacy Studies of rHSA/GCSF Fusion Protein For Injection to Treat Neutropenia Phase 1