The Phase I Study of Recombinant Human Nerve Growth Factor Injection
NCT ID: NCT04232332
Last Updated: 2021-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
86 participants
INTERVENTIONAL
2019-12-26
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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3.75μg (pre test)
Single dose
Recombinant human nerve growth factor injection,experimental
Intramuscular injection once on the first day according to dose requirements
7.5μg
Single dose
Recombinant human nerve growth factor injection,experimental
Intramuscular injection once on the first day according to dose requirements
15μg single dose
Intramuscular injection once
Recombinant human nerve growth factor injection,single dose
Intramuscular injection once on the first day according to dose requirements
30μg single dose
Intramuscular injection once
Recombinant human nerve growth factor injection,single dose
Intramuscular injection once on the first day according to dose requirements
45μg single dose
Intramuscular injection once
Recombinant human nerve growth factor injection,single dose
Intramuscular injection once on the first day according to dose requirements
60μg single dose
Intramuscular injection
Recombinant human nerve growth factor injection,single dose
Intramuscular injection once on the first day according to dose requirements
75μg single dose
Intramuscular injection
Recombinant human nerve growth factor injection,single dose
Intramuscular injection once on the first day according to dose requirements
90μg single dose
Intramuscular injection once
Recombinant human nerve growth factor injection,single dose
Intramuscular injection once on the first day according to dose requirements
30μg multiple dose
The dosage will be adjusted according to the actual situation of the trial
Recombinant human nerve growth factor injection,multiple dose
Intramuscular injection once daily for 7 days according to dose requirements
45μg multiple dose
The dosage will be adjusted according to the actual situation of the trial
Recombinant human nerve growth factor injection,multiple dose
Intramuscular injection once daily for 7 days according to dose requirements
Interventions
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Recombinant human nerve growth factor injection,experimental
Intramuscular injection once on the first day according to dose requirements
Recombinant human nerve growth factor injection,single dose
Intramuscular injection once on the first day according to dose requirements
Recombinant human nerve growth factor injection,multiple dose
Intramuscular injection once daily for 7 days according to dose requirements
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
ALL
Yes
Sponsors
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Beijing Tongren Hospital
OTHER
Responsible Party
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Principal Investigators
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Xiuli Zhao
Role: PRINCIPAL_INVESTIGATOR
Beijing Tongren Hospital
Locations
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Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PR-JSZX-2019015F
Identifier Type: -
Identifier Source: org_study_id
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