None
Conditions
Interventions
experimental group:0.16mg/kg, 0.4mg/kg, 0.8mg/kg, 1.4mg/kg, 2.0mg/kg or 2.4mg/kg, Subcutaneous injection of GB08 injection, single administration
control group:0.16mg/kg, 0.4mg/kg, 0.8mg/kg, 1.4mg/kg, 2.0mg/kg or 2.4mg/kg, subcutaneous injection of placebo, single administration
control group:0.035mg/kg, subcutaneous injection of recombinant human growth hormone injection once daily for 7 days
comparison group:0.2mg/kg, subcutaneous injection of Polyethylene glycol recombinant human growth hormone injection, single administration
Sponsors
Chengdu Fifth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must give informed consent to the study and fully understand the content, procedure and possible adverse effects of the trial prior to the trial, and voluntarily sign a written ICF; 2. Male and female subjects between the ages of 18 and 45 years (both 18 and 45 years) 3. Body weight: Male subjects should not be less than 50 kg, female subjects should not be less than 45 kg, and body mass index (BMI) should be within the range of 18.5-26.0 kg/m2 (including borderline values) [BMI = weight (kg)/height2 (m2)]; 4. The subject or partner must be willing to use a medically acceptable method of contraception for a period of 6 months from the signing of the ICF to the end of the trial, and the subject must not have used non pharmacological methods of contraceptives (such as condoms or intrauterine devices, etc.) from the signing of the ICF to the end of the trial; 5. The subject is able to communicate well with the investigator and is able to complete the study in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. The subject has a history of food or drug allergy, including a known history of allergy to the test drug or class of drugs or any excipients; 2.Have a clinically significant pulmonary, hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal (e.g., peptic ulcer disease), neoplastic (persons with a history of intracranial tumors, such as pituitary tumors or meningiomas; patients with active malignancies; persons with a history of prior malignancies), immune, skin, hematologic, or metabolic disorder, or any other disease or a history of any of these disorders, which in the opinion of the investigator, or would jeopardize the subject's safety or affect the results of the study; 3. Subject has a history of diabetes mellitus or fasting blood glucose greater than the upper limit of normal (ULN) found at screening; 4. Subject has a history of clinically significant thyroid disease or an elevated and clinically significant thyrotropin (TSH) at screening; 5. Subjects with abnormal findings on physical examination, vital signs, laboratory tests (routine blood, coagulation, blood biochemistry, urinalysis, etc.), and 12-lead electrocardiogram, and where the abnormality is judged by the investigator to be clinically significant; 6. QTcF > 450ms on 12-lead ECG at subject screening; 7. Subject has a history of positive serologic test results, or current abnormal results of clinical significance: Hepatitis B surface antigen, Hepatitis C antibodies, Human Immunodeficiency Virus (HIV) antibodies, Syphilis spirochete antibodies; 8. Subject has a history of fundus lesions (optic nerve papillary edema lesions); 9. The subject has had a serious infection within 3 months prior to screening or has had symptoms of infection within 7 days prior to screening that, in the judgment of the investigator, makes the participant unsuitable; 10. Acute illness or concomitant medication in the subject from the screening phase until study drug administration; 11.Subject has a history of substance abuse or a positive screen for substance abuse, or habitual use of any medication, including herbal remedies; 12. Excessive smoking (=5 cigarettes/day) within 3 months prior to screening or within 48h prior to the first dose of study medication or inability to interrupt smoking during the trial; 13.Subject has a history of alcohol abuse or alcoholism in the 3 months prior to screening, or those who had consumed alcohol within 48h prior to the first dose of the study or who tested positive for alcohol at screening or who were unable to interrupt their drinking during the trial. Alcohol abuse was defined as consumption of more than 14 units of alcoholic beverages per week (1 unit = 285 ml of beer, or 25 ml of spirits, or 100 ml of wine); 14. Subjects who have participated in any drug or medical device clinical trial within 90 days prior to screening; 15. Female subjects who are breastfeeding or have a positive pregnancy test during the screening period or during the course of the trial; 16. Subjects were vaccinated within 3 months prior to screening; 17.Subjects had a history of blood donation or significant blood loss (=400 ml) within 3 months prior to screening; 18. Subject has begun a significantly abnormal diet (e.g., diet, low sodium) within 4 weeks prior to screening, or subject has lost more than 5.0% of total body weight in the 180 days prior to randomization; 19. The subject has used any prescription, over-the-counter, nutraceutical, or herba
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of maximum tolerated dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic evaluation index: PK parameters (Cmax, AUC0-t, AUC0-inf, Tmax, ?z, t1/2, Vd/F, CL/F, AUC_%Extrap) ;Pharmacokinetic evaluation indexes: PD parameters (observed Emax, TEmax, AUEC0-t, AUEC0-24h, etc. for IGF-1, IGFBP-3) ;Indicators of immunogenicity evaluation: positivity for anti-drug antibodies (ADA); further characterization of ADA-positive samples to determine the titer of ADA and to detect the presence of neutralizing antibodies (NAb); | — |
Countries
CHINA
Contacts
Public ContactWen He
Chengdu Fifth People's Hospital
Outcome results
None listed