Injury of Optic NervePhase 1NCT04232332
The Phase I Study of Recombinant Human Nerve Growth Factor Injection
A Phase 1 study testing Recombinant human nerve growth factor injection,experimental, Recombinant human nerve growth factor injection,single dose and Recombinant human nerve growth factor injection,multiple dose in people with Injury of Optic Nerve, run by Beijing Tongren Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury of Optic Nerve
- What is being tested?
- Recombinant human nerve growth factor injection,experimental, Recombinant human nerve growth factor injection,single dose and Recombinant human nerve growth factor injection,multiple dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2019to 31 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Feng Wu, 010-58268422, bjtrec@126.com
Xiuli Zhao
About this study
Official title: 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
Read the 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.
- Conditions
- Injury of Optic Nerve
- Being tested
- Recombinant human nerve growth factor injection,experimental, Recombinant human nerve growth factor injection,single dose, Recombinant human nerve growth factor injection,multiple dose
- Medical subject headings
- Optic Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human nerve growth factor injection,experimentalDrug
Also called Experimental
Intramuscular injection once on the first day according to dose requirements
Recombinant human nerve growth factor injection,single doseDrug
Also called Placebo
Intramuscular injection once on the first day according to dose requirements
Recombinant human nerve growth factor injection,multiple doseDrug
Also called Placebo
Intramuscular injection once daily for 7 days according to dose requirements
| Study group | Role | What they receive |
|---|---|---|
| 3.75μg (pre test) | Experimental | Single dose Receives: Drug: Recombinant human nerve growth factor injection,experimental |
| 7.5μg | Experimental | Single dose Receives: Drug: Recombinant human nerve growth factor injection,experimental |
| 15μg single dose | Placebo comparator | Intramuscular injection once Receives: Drug: Recombinant human nerve growth factor injection,single dose |
| 30μg single dose | Placebo comparator | Intramuscular injection once Receives: Drug: Recombinant human nerve growth factor injection,single dose |
| 45μg single dose | Placebo comparator | Intramuscular injection once Receives: Drug: Recombinant human nerve growth factor injection,single dose |
| 60μg single dose | Placebo comparator | Intramuscular injection Receives: Drug: Recombinant human nerve growth factor injection,single dose |
| 75μg single dose | Placebo comparator | Intramuscular injection Receives: Drug: Recombinant human nerve growth factor injection,single dose |
| 90μg single dose | Placebo comparator | Intramuscular injection once Receives: Drug: Recombinant human nerve growth factor injection,single dose |
| 30μg multiple dose | Placebo comparator | The dosage will be adjusted according to the actual situation of the trial Receives: Drug: Recombinant human nerve growth factor injection,multiple dose |
| 45μg multiple dose | Placebo comparator | The dosage will be adjusted according to the actual situation of the trial Receives: Drug: Recombinant human nerve growth factor injection,multiple dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Single dose: 24 hours / Multiple doses: 8 days
Secondary outcomes (1)
Percentage of Participants With anti-drug antibodies
Percentage of participants with treatment-emergent positive anti-drug antibodies was summarized by treatment group.
Measured: Single dose: 28 days / Multiple dose: 34 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start26 Dec 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Optic NerveStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiuli Zhao, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232332
- Sponsor's protocol ID
- PR-JSZX-2019015F
- Status last verified
- Aug 2021
- First submitted
- 12 Jan 2020
- Last updated
- 17 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04232332
- Acronym / sponsor ID
- PR-JSZX-2019015F
- Conditions
- Injury of Optic Nerve
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 26 Dec 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 3.75μg (pre test) | Experimental | Drug: Recombinant human nerve growth factor injection,experimentalSingle dose |
| 7.5μg | Experimental | Drug: Recombinant human nerve growth factor injection,experimentalSingle dose |
| 15μg single dose | Placebo comparator | Drug: Recombinant human nerve growth factor injection,single doseIntramuscular injection once |
| 30μg single dose | Placebo comparator | Drug: Recombinant human nerve growth factor injection,single doseIntramuscular injection once |
| 45μg single dose | Placebo comparator | Drug: Recombinant human nerve growth factor injection,single doseIntramuscular injection once |
| 60μg single dose | Placebo comparator | Drug: Recombinant human nerve growth factor injection,single doseIntramuscular injection |
| 75μg single dose | Placebo comparator | Drug: Recombinant human nerve growth factor injection,single doseIntramuscular injection |
| 90μg single dose | Placebo comparator | Drug: Recombinant human nerve growth factor injection,single doseIntramuscular injection once |
| 30μg multiple dose | Placebo comparator | Drug: Recombinant human nerve growth factor injection,multiple doseThe dosage will be adjusted according to the actual situation of the trial |
| 45μg multiple dose | Placebo comparator | Drug: Recombinant human nerve growth factor injection,multiple doseThe dosage will be adjusted according to the actual situation of the trial |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human nerve growth factor injection,experimentalAlso: ExperimentalIntramuscular injection once on the first day according to dose requirements | Drug | 3.75μg (pre test), 7.5μg |
| Recombinant human nerve growth factor injection,single doseAlso: PlaceboIntramuscular injection once on the first day according to dose requirements | Drug | 15μg single dose, 30μg single dose, 45μg single dose, 60μg single dose, 75μg single dose, 90μg single dose |
| Recombinant human nerve growth factor injection,multiple doseAlso: PlaceboIntramuscular injection once daily for 7 days according to dose requirements | Drug | 30μg multiple dose, 45μg multiple dose |
Primary outcome
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.
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
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
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
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
1 secondary outcome
Percentage of Participants With anti-drug antibodies
Time frame: Single dose: 28 days / Multiple dose: 34 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuli Zhao principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant human nerve growth factor injection,experimental, Recombinant human nerve growth factor injection,single dose and Recombinant human nerve growth factor injection,multiple dose in people with Injury of Optic Nerve, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Wu (010-58268422, bjtrec@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Single dose: 28 days / Multiple dose: 34 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.