The Phase I Study of Recombinant Human Nerve Growth Factor Injection (NCT04232332) | Clinical Trial Compass
UnknownPhase 1
The Phase I Study of Recombinant Human Nerve Growth Factor Injection
China86 participantsStarted 2019-12-26
Plain-language 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
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events
Timeframe: Single dose: 28 days / Multiple dose: 34 days
2
Area under curve (AUC) after injection of single dose/multiple dose
Timeframe: Single dose: 24 hours / Multiple doses: 8 days
3
Cmax after injection of single dose/multiple dose
Timeframe: Single dose: 24 hours / Multiple doses: 8 days
4
Tmax after injection of single dose/multiple dose
Timeframe: Single dose: 24 hours / Multiple doses: 8 days
5
T1/2 after injection of single dose/multiple dose
Timeframe: Single dose: 24 hours / Multiple doses: 8 days
. 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;