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 range18 Years – 45 Years

SexALL

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;
✕. 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;

What they're measuring

Incidence of adverse events

Timeframe: Single dose: 28 days / Multiple dose: 34 days

Area under curve (AUC) after injection of single dose/multiple dose

Timeframe: Single dose: 24 hours / Multiple doses: 8 days

Cmax after injection of single dose/multiple dose

Timeframe: Single dose: 24 hours / Multiple doses: 8 days

Tmax after injection of single dose/multiple dose

Timeframe: Single dose: 24 hours / Multiple doses: 8 days

T1/2 after injection of single dose/multiple dose

Timeframe: Single dose: 24 hours / Multiple doses: 8 days

Trial details

NCT IDNCT04232332

SponsorBeijing Tongren Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

Contact for this trial

Feng Wu

010-58268422 bjtrec@126.com

View on ClinicalTrials.gov More Injury of Optic Nerve trials

Who can participate

Age range18 Years – 45 Years

SexALL

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;
✕. 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;

What they're measuring

Incidence of adverse events

Timeframe: Single dose: 28 days / Multiple dose: 34 days

Area under curve (AUC) after injection of single dose/multiple dose

Timeframe: Single dose: 24 hours / Multiple doses: 8 days

Cmax after injection of single dose/multiple dose

Timeframe: Single dose: 24 hours / Multiple doses: 8 days

Tmax after injection of single dose/multiple dose

Timeframe: Single dose: 24 hours / Multiple doses: 8 days

T1/2 after injection of single dose/multiple dose

Timeframe: Single dose: 24 hours / Multiple doses: 8 days