growth hormone deficiency,GHD
Conditions
Interventions
TR group:Participants received subcutaneous injections of the test formulation (T) ?the reference formulation (R) in the abdomen at a dose of 4 mg, and after a 14-day washout period, they were crossed
RT group:Participants received subcutaneous injections of the reference formulation (R)?the test formulation (T) in the abdomen at a dose of 4 mg, and after a 14-day washout period, they were crosse
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participants who, prior to the trial, have been fully informed of the nature, significance and potential benefits of the trial, as well as any inconvenience, potential risks and discomfort it may entail; who have voluntarily agreed to participate in this clinical trial; who are able to communicate effectively with the investigator; who are willing to comply with all requirements of the study; and who have signed a written informed consent form; 2. Participants aged 18 or over (including those aged 18); 3. Men >= 50 kg, women >= 45 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m^2 (including the cut-off values); body mass index (BMI) = weight (kg) / height^2 (m^2); 4. Participants and their female partners must agree not to plan a pregnancy from 2 weeks prior to screening until 6 months after the final dose of the study drug, must voluntarily use effective contraception, and must not plan to donate sperm or eggs; they must also undertake to use one or more non-pharmacological methods of contraception during sexual intercourse from 2 weeks prior to screening until 1 month after the final dose of the study drug; 5. The researcher determined that the participant was in good health.
Exclusion criteria
Exclusion criteria: 1. Results from vital signs, 12-lead electrocardiograms, chest X-rays and laboratory tests (complete blood count, urinalysis, electrolytes, liver function, kidney function, lipid profile, fasting blood glucose, coagulation tests, etc.) during the screening period, which are deemed clinically significant by the attending clinician; 2. Individuals with a history of any clinically significant medical conditions, including but not limited to disorders of the digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, neuropsychiatric, haematological and immune systems, as well as metabolic disorders; 3. Individuals who tested positive for hepatitis B surface antigen, hepatitis C virus antibodies or syphilis antibodies during the screening period, or who tested positive for HIV; 4. Individuals who are allergic to the study drug, including maintenance medication and any of its components, or who have a history of allergic conditions or a predisposition to allergies; 5. Exclude participants who have lost or donated more than 400 mL of blood, received a blood transfusion or used blood products within the preceding three months, or who plan to donate blood during the trial or within three months of its completion; 6. Exclude participants who have undergone major surgery within the preceding three months, or who have undergone surgery that may significantly affect the pharmacokinetics of the study drug or the assessment of its safety; 7. Individuals who have taken any prescription or over-the-counter medicines, herbal remedies or health supplements within the two weeks prior to screening, or who are still within the five-half-life period of any medication at the time of screening; 8. Participants who have taken part in other clinical trials within the past three months, or who plan to take part in other clinical trials during the course of this study; 9. Exclude participants who have engaged in heavy or frequent drinking within the preceding six months (defined as consuming more than 14 standard units of alcohol per week, where 1 unit = 357 ml of 5% ABV beer, 43 ml of 40% ABV spirits, or 147 ml of 12% ABV wine); or who have tested positive for alcohol in a blood test; or who do not agree to abstain from alcohol during the trial; 10. Participants who were heavy smokers within the six months prior to screening (smoking more than five cigarettes or the equivalent amount of tobacco per day within the six months prior to screening) or who were unable to give up smoking during the trial; 11. Exclude those who, on average, consumed more than 1 litre of tea, coffee or caffeinated drinks per day during the month prior to screening; 12. Those with a history of substance abuse or who have tested positive in a substance abuse screening; 13. Those with a history of retinal lesions (optic disc oedema); 14. Those with special dietary requirements, or who are unable to adhere to the standard meals; 15. Those who experience fainting at the sight of needles or blood, or who are unable to tolerate venipuncture or have difficulty with blood collection; 16. Participants who are unable to complete the study for other reasons, or whom the investigator considers unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t, AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| PD indicator;Adverse events; | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed