- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04232332
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
Recruiting
Conditions
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
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
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
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 18-45 years old, including boundary value;
- 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);
- volunteers participated in the study voluntarily and signed informed consent.
Exclusion Criteria:
- Take any prescription or over-the-counter drugs within 2 weeks before screening;
- Those who have been vaccinated within 3 months before screening;
- Those who participated in any clinical trial within 3 months before screening;
- 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;
- Diseases with clinical significance within 2 weeks before screening;
- Those who had major surgery, trauma or hospitalization within 6 months before screening;
- There is tattoo or other influence on the injection site to observe the skin condition;
- 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;
- There is a significant history of allergy in clinic, especially the history of drug allergy, especially the allergy to any component of zx1305 injection;
- 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;
- 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;
- Those who smoked more than 5 cigarettes per day in the first half year of screening;
- 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;
- 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;
- The condition of peripheral venous access is poor (difficult to collect blood);
- 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 |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 3.75μg (pre test)
Single dose
|
Intramuscular injection once on the first day according to dose requirements
Other Names:
|
EXPERIMENTAL: 7.5μg
Single dose
|
Intramuscular injection once on the first day according to dose requirements
Other Names:
|
PLACEBO_COMPARATOR: 15μg single dose
Intramuscular injection once
|
Intramuscular injection once on the first day according to dose requirements
Other Names:
|
PLACEBO_COMPARATOR: 30μg single dose
Intramuscular injection once
|
Intramuscular injection once on the first day according to dose requirements
Other Names:
|
PLACEBO_COMPARATOR: 45μg single dose
Intramuscular injection once
|
Intramuscular injection once on the first day according to dose requirements
Other Names:
|
PLACEBO_COMPARATOR: 60μg single dose
Intramuscular injection
|
Intramuscular injection once on the first day according to dose requirements
Other Names:
|
PLACEBO_COMPARATOR: 75μg single dose
Intramuscular injection
|
Intramuscular injection once on the first day according to dose requirements
Other Names:
|
PLACEBO_COMPARATOR: 90μg single dose
Intramuscular injection once
|
Intramuscular injection once on the first day according to dose requirements
Other Names:
|
PLACEBO_COMPARATOR: 30μg multiple dose
The dosage will be adjusted according to the actual situation of the trial
|
Intramuscular injection once daily for 7 days according to dose requirements
Other Names:
|
PLACEBO_COMPARATOR: 45μg multiple dose
The dosage will be adjusted according to the actual situation of the trial
|
Intramuscular injection once daily for 7 days according to dose requirements
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
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)
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
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
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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