The Phase I Study of Recombinant Human Nerve Growth Factor Injection

Capital Medical University

Status and phase: Unknown; Phase 1

Conditions: Injury of Optic Nerve

Treatments: Drug: Recombinant human nerve growth factor injection,experimental; Drug: Recombinant human nerve growth factor injection,multiple dose; Drug: Recombinant human nerve growth factor injection,single dose

Study type: Interventional

Funder types: Other

Identifiers

NCT04232332

PR-JSZX-2019015F

Details and patient eligibility

About

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

Full description

This is a randomized, double-blind, placebo-controlled, single / multiple dose trial. recombinant human nerve growth factor injection in healthy Chinese volunteers on safety, and pharmacokinetics.The volunteers will be given the drug by intramuscular injection. The main purpose of this trial is to investigate the safety, tolerability , pharmacokinetics and immunogenicity of Chinese healthy volunteers after intramuscular injection of recombinant human nerve growth factor injection, to provide a safe dose range for subsequent clinical trials, as well as a safe and reasonable drug delivery program.

Enrollment: 86 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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86 participants in 10 patient groups, including a placebo group

3.75μg (pre test)

Experimental group

Description:

Single dose

Treatment:

Drug: Recombinant human nerve growth factor injection,experimental

7.5μg

Experimental group

Description:

Single dose

Treatment:

Drug: Recombinant human nerve growth factor injection,experimental

15μg single dose

Placebo Comparator group

Description:

Intramuscular injection once

Treatment:

Drug: Recombinant human nerve growth factor injection,single dose

30μg single dose

Placebo Comparator group

Description:

Intramuscular injection once

Treatment:

Drug: Recombinant human nerve growth factor injection,single dose

45μg single dose

Placebo Comparator group

Description:

Intramuscular injection once

Treatment:

Drug: Recombinant human nerve growth factor injection,single dose

60μg single dose

Placebo Comparator group

Description:

Intramuscular injection

Treatment:

Drug: Recombinant human nerve growth factor injection,single dose

75μg single dose

Placebo Comparator group

Description:

Intramuscular injection

Treatment:

Drug: Recombinant human nerve growth factor injection,single dose

90μg single dose

Placebo Comparator group

Description:

Intramuscular injection once

Treatment:

Drug: Recombinant human nerve growth factor injection,single dose

30μg multiple dose

Placebo Comparator group

Description:

The dosage will be adjusted according to the actual situation of the trial

Treatment:

Drug: Recombinant human nerve growth factor injection,multiple dose

45μg multiple dose

Placebo Comparator group

Description:

The dosage will be adjusted according to the actual situation of the trial

Treatment:

Drug: Recombinant human nerve growth factor injection,multiple dose