Tumor
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGKeytruda®(US)
intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose)
DRUGQL2107
intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose)
DRUGKeytruda®(china)
intravenous infusion 35 min (±5min, minimum infusion 30min), D1 (Day 1, single dose)
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements; 2. Age 18 \ 50 (inclusive) years , male; 3. 50.0 kg≤ body weight ≤90.0 kg and 18.0 kg/m2≤ Body mass index (BMI) ≤28.0 kg/m2; 4. Agree to use effective contraception throughout the study period (including but not limited to: physical contraception, surgery, abstinence, etc.) until at least 6 months after the study dosing; 5. No history of disease or abnormal past medical history is not clinically significant, and the study doctor's judgment has no impact on the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-∞ | 113day | To evaluate pharmacokinetic similarity between QL2107 and Keytruda® (china/US)after a single intravenous infusion in healthy volunteers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 113day | To evaluate pharmacokinetic similarity between QL2107 and Keytruda® |
| Tmax | 113day | To evaluate pharmacokinetic similarity between QL2107 and Keytruda® |
| AUC0-t | 113day | To evaluate pharmacokinetic similarity between QL2107 and Keytruda® |
| safety and immunogenicity | 113day | Safety, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.after a single intravenous infusion in healthy volunteers;Immunogenicity will be assessed by the incidence of ADA and Nab. |
| CL | 113day | To evaluate pharmacokinetic similarity between QL2107 and Keytruda® |
| Vd | 113day | To evaluate pharmacokinetic similarity between QL2107 and Keytruda® |
| AUC_%Extrap | 113day | To evaluate pharmacokinetic similarity between QL2107 and Keytruda® |
| t1/2 | 113day | To evaluate pharmacokinetic similarity between QL2107 and Keytruda® |
Countries
China
Contacts
Primary Contactyanhua ding
Outcome results
None listed