The Phase I Study of Recombinant Human Nerve Growth Factor Injection

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

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

Study Overview

• Status: Recruiting
• Conditions: Injury of Optic Nerve
• Intervention / Treatment: Drug: Recombinant human nerve growth factor injection,experimental; Drug: Recombinant human nerve growth factor injection,single dose; Drug: Recombinant human nerve growth factor injection,multiple dose

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 Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Feng Wu; Phone Number: 010-58268422; Email: bjtrec@126.com
• Study Contact Backup: Name: Yi Zhang; Phone Number: 025-58310595; Email: Zhang.Yi@xintrum.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Beijing Tongren Hospital
      • Contact: Feng Wu; Phone Number: 010-58268422; Email: bjtrec@126.com
      • Principal Investigator: Xiuli Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: TRIPLE

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 3.75μg (pre test); Single dose	Drug: Recombinant human nerve growth factor injection,experimental; Intramuscular injection once on the first day according to dose requirements; Other Names: Experimental
EXPERIMENTAL: 7.5μg; Single dose	Drug: Recombinant human nerve growth factor injection,experimental; Intramuscular injection once on the first day according to dose requirements; Other Names: Experimental
PLACEBO_COMPARATOR: 15μg single dose; Intramuscular injection once	Drug: Recombinant human nerve growth factor injection,single dose; Intramuscular injection once on the first day according to dose requirements; Other Names: Placebo
PLACEBO_COMPARATOR: 30μg single dose; Intramuscular injection once	Drug: Recombinant human nerve growth factor injection,single dose; Intramuscular injection once on the first day according to dose requirements; Other Names: Placebo
PLACEBO_COMPARATOR: 45μg single dose; Intramuscular injection once	Drug: Recombinant human nerve growth factor injection,single dose; Intramuscular injection once on the first day according to dose requirements; Other Names: Placebo
PLACEBO_COMPARATOR: 60μg single dose; Intramuscular injection	Drug: Recombinant human nerve growth factor injection,single dose; Intramuscular injection once on the first day according to dose requirements; Other Names: Placebo
PLACEBO_COMPARATOR: 75μg single dose; Intramuscular injection	Drug: Recombinant human nerve growth factor injection,single dose; Intramuscular injection once on the first day according to dose requirements; Other Names: Placebo
PLACEBO_COMPARATOR: 90μg single dose; Intramuscular injection once	Drug: Recombinant human nerve growth factor injection,single dose; Intramuscular injection once on the first day according to dose requirements; Other Names: Placebo
PLACEBO_COMPARATOR: 30μg multiple dose; The dosage will be adjusted according to the actual situation of the trial	Drug: Recombinant human nerve growth factor injection,multiple dose; Intramuscular injection once daily for 7 days according to dose requirements; Other Names: Placebo
PLACEBO_COMPARATOR: 45μg multiple dose; The dosage will be adjusted according to the actual situation of the trial	Drug: Recombinant human nerve growth factor injection,multiple dose; Intramuscular injection once daily for 7 days according to dose requirements; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 26, 2019
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): March 31, 2022

Study Registration Dates

• First Submitted: January 12, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (ACTUAL): January 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Optic Nerve Diseases; Cranial Nerve Diseases; Cranial Nerve Injuries; Optic Nerve Injuries; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: PR-JSZX-2019015F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No