The Phase I Study of Recombinant Human Nerve Growth Factor Injection

August 10, 2021 updated by: Beijing Tongren Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital
        • Contact:
        • Principal Investigator:
          • Xiuli Zhao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: 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.
Single dose: 28 days / Multiple dose: 34 days
Area under curve (AUC) after injection of single dose/multiple dose
Time Frame: Single dose: 24 hours / Multiple doses: 8 days
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
Time Frame: Single dose: 24 hours / Multiple doses: 8 days
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
Time Frame: Single dose: 24 hours / Multiple doses: 8 days
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
Time Frame: Single dose: 24 hours / Multiple doses: 8 days
To measure the drug concentration in blood samples which collected after injection
Single dose: 24 hours / Multiple doses: 8 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With anti-drug antibodies
Time Frame: Single dose: 28 days / Multiple dose: 34 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 26, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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