The Phase I Study of Recombinant Human Nerve Growth Factor Injection

Phase 1

• Conditions: Injury of Optic Nerve
• Interventions: Drug: Recombinant human nerve growth factor injection,single dose; Drug: Recombinant human nerve growth factor injection,experimental; Drug: Recombinant human nerve growth factor injection,multiple dose

• Registration Number: NCT04232332
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-12-26
• Study First Submitted: 2020-01-12
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-10
• Last Update Posted: 2021-08-17
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
90μg single dose	Recombinant human nerve growth factor injection,single dose	Intramuscular injection once
3.75μg (pre test)	Recombinant human nerve growth factor injection,experimental	Single dose
7.5μg	Recombinant human nerve growth factor injection,experimental	Single dose
15μg single dose	Recombinant human nerve growth factor injection,single dose	Intramuscular injection once
30μg single dose	Recombinant human nerve growth factor injection,single dose	Intramuscular injection once
45μg single dose	Recombinant human nerve growth factor injection,single dose	Intramuscular injection once
60μg single dose	Recombinant human nerve growth factor injection,single dose	Intramuscular injection
75μg single dose	Recombinant human nerve growth factor injection,single dose	Intramuscular injection
30μg multiple dose	Recombinant human nerve growth factor injection,multiple dose	The dosage will be adjusted according to the actual situation of the trial
45μg multiple dose	Recombinant human nerve growth factor injection,multiple dose	The dosage will be adjusted according to the actual situation of the trial

Primary Outcome Measures

Name	Time	Method
Cmax after injection of single dose/multiple dose	Single dose: 24 hours / Multiple doses: 8 days	To measure the drug concentration in blood samples which collected after injection
Area under curve (AUC) after injection of single dose/multiple dose	Single dose: 24 hours / Multiple doses: 8 days	To measure the drug concentration in blood samples which collected after injection
Incidence of adverse events	Single dose: 28 days / Multiple dose: 34 days	Record the number of participants with abnormal laboratory values and/or adverse events,calculate frequency and percentage based on correlation with the investigational drug.
T1/2 after injection of single dose/multiple dose	Single dose: 24 hours / Multiple doses: 8 days	To measure the drug concentration in blood samples which collected after injection
Tmax after injection of single dose/multiple dose	Single dose: 24 hours / Multiple doses: 8 days	To measure the drug concentration in blood samples which collected after injection

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With anti-drug antibodies	Single dose: 28 days / Multiple dose: 34 days	Percentage of participants with treatment-emergent positive anti-drug antibodies was summarized by treatment group.

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China