stimulates the growth of the body
Conditions
Interventions
positive control:positive control (dosage 1)
Dosage 1 group (Test drug):Single injection of test drug of dose 1 (vs placebo control)
Dosage 1 group (placebo):Placebo (vs single injection of test drug of dose 1)
Dosage 2 group (Test drug):Single injection of test drug of dose 2 (vs placebo control)
Dosage 2 group (placebo):Placebo (vs single injection of test drug of dose 2)
Dosage 3 group (Test drug):Single injection of test drug of dose 3 (vs placebo control)
Dosage 3 group (placebo):Placebo (vs single injection of test drug of dose 3)
Dosage 4 group (Test drug):Single injection of test drug of dose 4 (vs placebo control)
Dosage 4 group (placebo):Placebo (vs single injection of test drug of dose 4)
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects shall sign the informed consent before the test and have a full understanding of the test content, process and possible adverse reactions; subjects voluntarily participate and complete the study according to the protocol. 2. Healthy male or female subjects aged 18 to 45 (based on the date of signing the informed consent form). 3. Weight >=50kg for males,>=45kg for females. BMI 19-26 kg/m^2 (including the critical value). 4. Subjects shall be in good health condition, with normal or abnormal results of all examination tests without clinical significance, and judged by the investigator to be eligible. 5. Subjects or his/her partner shall use appropriate and effective contraception, such as abstinence, oral contraceptives, IUDs, double barrier methods (e.g. condom plus diaphragm) during the trial or after signing of the informed consent form and have no plans to donate sperm or eggs or have children within 3 months after trial.
Exclusion criteria
Exclusion criteria: 1. History of chronic illnesses or serious illnesses such as neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematological and lymphatic, urinary, endocrine, immune system diseases, or any other disease and physiological condition that may affect the results of the trial. 2. Allergic person who had or currently suffers from clinically significant atopic allergic, hypersensitivity or anaphylactic reactions, including known or suspected hypersensitivity to a component of the test drug. 3. Persons with a history of drug or substance abuse. 4. Persons who have undergone surgery within 3 months prior to screening or are scheduled to undergo surgery during the trial, or who have undergone surgery that would interfere with the absorption, distribution, metabolism, or excretion of the drug. 5. Those who have taken any prescription, over-the-counter, herbal and nutraceutical medication within 2 weeks prior to screening. 6. Those who have participated in any other clinical trial and take medicine within 3 months prior to screening or who plan to participate in another clinical trial concurrently during the trial. 7. Those who have donated blood or blood products or lost >= 400 mL of blood during the 3 months prior to screening or planned to do so during the trial (except for bleeding during the female physiological period). 8. Those whose growth hormone exceeds the upper limit of normal during the screening and those who have used growth hormone within 3 months prior to the first administration. 9. Positive in any of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immune syndrome antibody (Anti-HIV) and anti-syphilis spirochete antibody (TP-Ab). 10. Excessive use of nicotine products (more than 5 cigarettes per day on average) in the 3 months prior to screening or inability to stop using any tobacco product during the trial. 11. Regular drinkers within 3 months prior to screening, i.e., drinking more than 14 units of alcohol per week (1 unit = 360mL of beer or 45mL of spirits at 40% alcohol or 150mL of wine) or those who have taken any alcohol-containing product within 24 hours prior to administration, or those who have a positive alcohol screen or who are unable to abstain from alcohol during the trial. 12. Those who have consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups on average, 1 cup ˜ 250 mL) per day in the 3 months prior to screening. 13. Persons who cannot tolerate venipuncture or who have potential difficulty in collecting blood or who suffer from blood or needle sickness. 14. Those who have received a vaccine (especially covid-19 vaccines) within 2 months prior to screening, or who plan to receive a vaccine (especially covid-19 vaccines) during or within 2 months after the trial. 15. Female volunteers who are pregnant or breastfeeding during the screening or during the trial. 16. Those who are unable to comply with the diet provided and the corresponding regulations. 17. Those who are unsuitable to participate in the clinical trial for various other reasons judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event;vital signs;Blood routine examination;urine routine examination;Blood biochemistry;Thyroid function tests;Adrenocortical function test;ECG;Tumor marker examination;Growth hormone test;Chest X ray examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| plasma concentration;ADA;IGF-1 level; | — |
Countries
China
Contacts
Public ContactWei hu
Drug Clinical Research Center, The Second Hospital of Anhui Medical University
Outcome results
None listed