Injury of Optic Nerve Clinical Trial
Official title:
The Phase I Study of Recombinant Human Nerve Growth Factor Injection in Healthy Chinese Volunteers on Safety, Tolerability and Pharmacokinetics: Randomized, Double-blind, Placebo-controlled, Single / Multiple Dose
| Verified date | August 2021 |
| Source | Beijing Tongren Hospital |
| Contact | Feng Wu |
| Phone | 010-58268422 |
| bjtrec[@]126.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A randomized, double-blind, placebo-controlled, single/multiple dose study of recombinant human nerve growth factor injection in healthy Chinese volunteers on safety, tolerability and pharmacokinetics
| Status | Recruiting |
| Enrollment | 86 |
| Est. completion date | March 31, 2022 |
| Est. primary completion date | December 31, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility | Inclusion Criteria: 1. Age: 18-45 years old, including boundary value; 2. The body weight meets the standard, the body weight of male volunteers is not less than 50kg, the body weight of female volunteers is not less than 45kg, the body mass index is in the range of 19-24kg / m2, the body mass index = body weight (kg) / height (M2); 3. volunteers participated in the study voluntarily and signed informed consent. Exclusion Criteria: 1. Take any prescription or over-the-counter drugs within 2 weeks before screening; 2. Those who have been vaccinated within 3 months before screening; 3. Those who participated in any clinical trial within 3 months before screening; 4. Those who lost blood or donated more than 200 ml blood within 4 weeks before screening or who intend to donate blood during the study or within 4 weeks after the end of the study; 5. Diseases with clinical significance within 2 weeks before screening; 6. Those who had major surgery, trauma or hospitalization within 6 months before screening; 7. There is tattoo or other influence on the injection site to observe the skin condition; 8. Patients with history of central nervous system, mental system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism system, blood system, immune system, endocrine system and skeletal muscle system may endanger the safety of the subjects or affect the research results according to the judgment of the researchers; 9. There is a significant history of allergy in clinic, especially the history of drug allergy, especially the allergy to any component of zx1305 injection; 10. The five items of hepatitis B (hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B e antigen, hepatitis B e antibody, hepatitis B core antibody), hepatitis C antibody, syphilis specific antibody or AIDS joint test have clinical significance; 11. It is suspected that there is alcohol dependence, and the average alcohol intake in the first half year of screening is more than 2 units per day (1 unit = 10ml alcohol, i.e. 1 unit = 200ml beer with 5% alcohol or 25ml spirits with 40% alcohol or 83ml wine with 12% alcohol) or the alcohol test is positive; 12. Those who smoked more than 5 cigarettes per day in the first half year of screening; 13. Those who had a history of drug abuse or had taken drugs within one year before screening, or who were positive in urine test of ketamine, morphine, methamphetamine, dimethyldioxygoamphetamine and tetrahydrocannabinolic acid; 14. Women who are positive in pregnancy, lactation, blood pregnancy or who have not taken effective contraceptive measures in the last month, and men or women who are not willing to take effective non drug contraceptive measures during the whole trial period and who are not willing to take effective contraceptive measures within one year after the end of the trial; 15. The condition of peripheral venous access is poor (difficult to collect blood); 16. There are other reasons that the researchers think should not be selected. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Tongren Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Tongren Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of adverse events | Record the number of participants with abnormal laboratory values and/or adverse events,calculate frequency and percentage based on correlation with the investigational drug. | Single dose: 28 days / Multiple dose: 34 days | |
| Primary | Area under curve (AUC) after injection of single dose/multiple dose | To measure the drug concentration in blood samples which collected after injection | Single dose: 24 hours / Multiple doses: 8 days | |
| Primary | Cmax after injection of single dose/multiple dose | To measure the drug concentration in blood samples which collected after injection | Single dose: 24 hours / Multiple doses: 8 days | |
| Primary | Tmax after injection of single dose/multiple dose | To measure the drug concentration in blood samples which collected after injection | Single dose: 24 hours / Multiple doses: 8 days | |
| Primary | T1/2 after injection of single dose/multiple dose | To measure the drug concentration in blood samples which collected after injection | Single dose: 24 hours / Multiple doses: 8 days | |
| Secondary | Percentage of Participants With anti-drug antibodies | Percentage of participants with treatment-emergent positive anti-drug antibodies was summarized by treatment group. | Single dose: 28 days / Multiple dose: 34 days |