Slow growth in children due to endogenous growth hormone deficiency (GHD)
Conditions
Interventions
Group 1:0.16mg/kg CCIBPR01005/placebo single dose subcutaneous injection
Group 2:0.4mg/kg CCIBPR01005/placebo single dose subcutaneous injection
Group 3:0.8mg/kg CCIBPR01005/placebo single dose subcutaneous injection
Group 4:1.2mg/kg CCIBPR01005/placebo single dose subcutaneous injection
Group 5:1.6mg/kg CCIBPR01005/placebo single dose subcutaneous injection
Sponsors
Zhejiang Xiaoshan Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Participants must give informed consent to the study before the trial, fully understand the content, process, and potential adverse reactions of the trial, and voluntarily sign a written ICF; 2. healthy male subjects aged 18 to 45 years old (including 18 and 45 years old); 3. male subjects weighing no less than 50 kilograms, with a body mass index (BMI) within the range of 19-26.0 kg/m^2 (including boundary values) [BMI=weight (kg)/height ^2 (m^2)]; 4. From the signing of the ICF until 3 months after the last administration, subjects (including partners) must be willing to use medically acceptable contraceptive methods (such as condoms or intrauterine devices); 5. The subjects are able to communicate well with the researchers and complete the study according to the protocol.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of food or drug allergies, including those known to have allergies to investigational drugs, growth hormone drugs, or any excipients; 2. Researchers consider clinically significant diseases such as lung, liver, kidney, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal (such as peptic ulcer disease), tumors (those with a history of intracranial tumors such as pituitary tumors and meningiomas; active malignant tumor patients; those with a history of previous malignant tumors), immune, skin, blood, or metabolic disorders, or any other diseases, or factors with a history of these diseases that may endanger the safety of subjects or affect research results; 3. Have a history of diabetes or find that the glucose metabolism index is greater than the upper limit of normal value (ULN) during screening; 4. Researchers believe that a history of thyroid disease with clinical significance or abnormal thyroid function test results during screening have clinical significance; 5. Abnormal results in physical examination, vital signs, laboratory tests (blood routine, coagulation function, blood biochemistry, urine routine, etc.), hormone testing, 12 lead electrocardiogram, etc., and judged by researchers to have clinical significance; 6. The result of serum virology test is positive, or the current result is abnormal and has clinical significance: hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus p24 antigen/antibody, treponema pallidum antibody; 7. Inquire about individuals with a history of retinal lesions (optic nerve papilledema); If there is a severe infection within 3 months before administration or symptoms of infection within 7 days before administration, and the researcher determines that it is not suitable for the participant; 8. Acute illness or concomitant medication occurred 2 weeks before administration to the study medication; 9. Within 2 years prior to administration, there is a history of drug abuse or a positive drug abuse screening result, or habitual use of any medication, including Chinese herbal medicine; 11. Smoking excessively (>= 5 cigarettes/day) within 3 months before administration, or smoking within 48 hours before study medication, or smoking should not be interrupted during the trial period; 12. Individuals who have a history of alcohol abuse or alcoholism within the past 3 months prior to drug administration, or who have consumed alcohol within 48 hours prior to drug administration or tested positive for alcohol before drug administration and cannot interrupt drinking during the trial period. The definition of alcoholism is: drinking more than 14 units of alcoholic beverages per week (1 unit=285ml of beer, 25ml of spirits, or 100ml of wine); 13. Individuals who have participated in any drug or medical device clinical trials within 90 days prior to administration (excluding those who have not used intervention drugs or experimental medical devices); 14. Vaccination should be administered within 3 months prior to administration; 15. Individuals who have donated blood or experienced significant blood loss (>= 400ml), received blood transfusions, or used blood products within 3 months prior to medication administration; 16. Within 14 days prior to administration, any prescription drugs, over-the-counter drugs, health supplements, or Chinese herbal medicines were used; Or using long-acting injections or implants; 17. Individuals who consume any fo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability;Pharmacokinetic (PK) Characteristics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic (PD) index;Immunogenicity; | — |
Countries
China
Contacts
Public ContactChen Jian
Zhejiang Xiaoshan Hospital
Outcome results
None listed