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This is a multiple-dose, dose-escalation, randomized, double-blind, placebo-controlled phase Ⅱa clinical trial. A total of 36 adult participants with growth hormone deficiency will be enrolled sequentially in ascending dose cohorts, and within each dose cohort, participants will be randomized in a 3:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group: Inpegsomatropin Injection low dose | Experimental |
| |
| A group:Placebo for Inpegsomatropin Injection low dose | Placebo Comparator |
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| B group: Inpegsomatropin Injection middle dose | Experimental |
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| B group:Placebo for Inpegsomatropin Injection middle dose | Placebo Comparator |
| |
| C group: Experimental:telpegfilgrastim Injection high | Experimental |
| |
| C group:Placebo for Inpegsomatropin Injection high dose | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inpegsomatropin Injection | Drug | Inpegsomatropin Injection,initial dose1mg/0.25ml, s.c. ,once a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 | |
| Serious Adverse Event | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 | |
| Number of Participants with Abnormal Laboratory Parameters Findings | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 | |
| HR (bpm) | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 | |
| PR (ms) | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 | |
| QRS (ms) | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 | |
| QT (ms) | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 | |
| QTc (ms) | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 | |
| Number of participants with clinically significant changes in imaging examinations | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 | |
| body weight | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 | |
| body Mass Index | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 |
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Inclusion Criteria:
Patients with a peak GH level < 5 μg/L measured by insulin tolerance test (ITT); OR Patients with an IGF-1 level below -2.0 SDS for age and sex at screening (see Appendix 4);
Exclusion Criteria:
Individuals with known or suspected hypersensitivity to the investigational product or its excipients;
Patients with severe malnutrition as judged by the investigator, or with a BMI < 18.5 kg/m² at screening;
Patients with active malignancy or a history of malignancy; or with thyroid nodules classified as TI-RADS grade ≥ 4a on thyroid ultrasound; or with high-risk or suspected malignant nodules detected on chest CT; or with clinically significant abnormal tumor markers at screening;
For patients with a history of pituitary adenoma or other benign intracranial tumors:
Patients with abnormal liver or renal function at screening (ALT > 3×ULN, Cr > 1.5×ULN);
Patients testing positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus antibody (anti-HIV) at screening;
Patients with a clinically significant change in body weight within 6 months prior to screening as judged by the investigator, or with a self-reported body weight change of ≥ 10% compared to 6 months before screening;
Patients with unstable control of diabetes mellitus within 3 months prior to screening (HbA1c ≥ 7.5% at screening), or with significant adjustment of hypoglycemic medication dose or change in therapeutic drug type, or with severe diabetic complications as judged by the investigator;
Patients with cardiac insufficiency classified as NYHA class ≥ III;
Patients with a history of acromegaly or gigantism;
Patients with mental disability or language impairment that prevents full participation in the trial;
Individuals who have participated in any clinical trial of investigational medicinal products (as a trial participant) and received investigational intervention within 3 months prior to screening;
Other conditions deemed unsuitable for enrollment by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiming Li, Ph.D | Contact | 13501936597 | yimingli@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yiming Li | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China |
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| Placebo for Inpegsomatropin Injection | Drug | Placebo for Inpegsomatropin Injection,initial dose0.25ml, s.c. ,once a week |
|
| Inpegsomatropin Injection | Drug | Inpegsomatropin Injection,initial dose 2mg/0.5ml, s.c. ,once a week |
|
| Placebo for Inpegsomatropin Injection | Drug | Placebo for Inpegsomatropin Injection,initial dose 0.5ml, s.c. ,once a week |
|
| Inpegsomatropin Injection | Drug | Inpegsomatropin Injection,initial dose 4mg/1ml, s.c. ,once a week |
|
| Placebo for Inpegsomatropin Injection | Drug | Placebo for Inpegsomatropin Injection,initial dose 1.0ml, s.c. ,once a wee |
|
| body temperature | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 |
| pulse | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 |
| blood pressure | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 |
| Respiration | Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37 |
| Trunk fat percentage | Week 25 |
| Trunk fat mass | Week 25 |
| Total fat mass | Week 25 |
| Visceral adipose tissue (VAT) | Week 25 |
| Lean body mass (LBM) | Week 25 |
| Bone mineral density (BMD) | Week 25 |
| Quality of life score (QoL score) | Week 25 |
| BMI | Week1Day1,Week25Day1 |
| Change from baseline in waist-to-hip ratio | Week3Day1,Week25Day1 |
| IGF-I /IGFBP-3 | Week1Day1,Week25Day1 |
| Cmax | Week1Day1,Week25Day1 |
| Cmin | Week1Day1,Week25Day1 |
| Tmax | Week1Day1,Week25Day1 |
| AUC0-t | Week1Day1,Week25Day1 |
| AUC0-∞ | Week1Day1,Week25Day1 |
| AUC0-tau | Week1Day1,Week25Day1 |
| Rac_Cmax | Week1Day1,Week25Day1 |
| Rac_AUC0-tau | Week1Day1,Week25Day1 |
| CL/F | Week1Day1,Week25Day1 |
| Vz/F | Week1Day1,Week25Day1 |
| DF | Week1Day1,Week25Day1 |
| t1/2 | Week1Day1,Week25Day1 |
| ADA | Week1Day1,Week29Day1 |
| NAb | Week1Day1,Week29Day1 |
| The First Affiliated Hospital of Henan University of Science and Technology | Henan | China |
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| Huashan Hospital, Fudan University | Shanghai | China |
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| West China Hospital, Sichuan University | Sichuan | China |
|
| The First Affiliated Hospital of Xiamen University | Xiamen | China |
|
| The Second Affiliated Hospital, Zhejiang University School of Medicine | Zhejiang | China |
|
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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