Cancer pain (including bone metastases)
Conditions
Interventions
Test:Accept a single SC administration of 3, 10, or 20 mg TNM009 or a single IV administration of 20, 40, or 60 mg TNM009.
Control:Accept a single SC or IV dose of placebo.
Sponsors
PKUCare Luzhong Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Signed and dated written informed consent; 2) Are willing and able to comply with scheduled visits, blood sampling, laboratory tests, and other study procedures; 3) Healthy male or female, 18-55 years of age (both inclusive); 4) Body mass index (BMI) within 19.0 – 28.0 kg/m2 (both inclusive) and body weight =50.0 kg for males and = 45.0 kg for females; 5) Have no clinically significant abnormality on physical examinations, vital signs, 12-lead ECG, clinical laboratory tests, liver function or kidney function as determined by Investigator; 6) Females must be either under surgical sterile (i.e., had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months before the dosing of study drug) or under postmenopausal for at least 1 year before the dosing of study drug or agree to use an effective method of contraception from screening until 120 days after study drug dosing. Males who are sexually active and who are partners of women of childbearing potential must agree to use an effective contraception from screening until 120 days after drug administration.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of osteoarthritis of the knee(s) or hip(s); 2. History of significant trauma or surgery to a major joint (e.g., hip, knee or shoulder) within 1 year prior to Screening; 3. History or evidence of any other acute or chronic disease that, in the opinion of the Investigators, may have interfered with the evaluation of the safety or immunogenicity of the drug or compromised the safety of the subject; 4. History of neuropathy or current active neuropathy; 5. Having evidence of orthostatic hypotension based upon replicate orthostatic blood pressure measurements at Screening or on Day -1; 6. Having chest X-ray abnormal findings with clinical significance at screening 7. Positive ?-interferon release test; 8. History of surgery (except minor outpatient surgery) within 3 months prior to screening, or planned surgery during the study; 9. Previous exposure to exogenous nerve growth factor or to an anti-nerve growth factor antibody; 10. Receipt of an Ig or blood product within 90 days prior to the drug administration; 11. Exposure to any live attenuated vaccine within 4 weeks prior to the drug administration 12. Any other drug used in the 14 days prior to drug administration; 13. Donated blood >400 mL or significant blood loss equivalent to 400 mL or received blood transfusion within 3 months of screening; or donated blood >200 mL or significant blood loss equivalent to 200 mL within 1 month prior to the screening; 14. Positive HBsAg, HCV-Ab, or HIV-Ab and syphilis tests at screening indicative of current infection; 15. Known or suspected history of drug abuse within the past 5 years or with positive urine drug test at Screening; 16. History of significant alcohol abuse within 6 months of screening; 17. Habitual use of nicotine products or smoking within 3 months (more than 5 cigarettes per day) prior to screening or unwilling to refrain from nicotine products during study participation; 18. Nursing mothers or pregnant women; 19. History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein; 20. Participation in any other clinical studies with chemical or biologic drugs or device within 4 weeks or 5 times the half-life of the specific drug/biologics (whichever is longer), prior to the drug administration; 21. Subjects who are considered unsuitable for participating in the study in the opinion of Investigators. 22. Researchers believe that the participants who are not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE;Standard safety assessments including physical examinations, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests (hematology, biochemistry, blood coagulation, and urinalysis); | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameter;AUC0-8(SC)/AUC0-8(IV);Anti-drug antibody (ADA) assessments; | — |
Countries
China
Contacts
Public ContactJie Hou
PKUCare Luzhong Hospital
Outcome results
None listed