A Phase II/III Clinical Trial Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency

Launched by SHENZHEN KEXING PHARMACEUTICAL CO., LTD. · Aug 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GB08 injection for children who have growth hormone deficiency, a condition where the body doesn’t produce enough growth hormone, leading to slower growth and shorter height. The study aims to find out if GB08 is as effective and safe as an existing treatment called Norditropin NordiFlex. It will also explore which dose of GB08 works best and whether its benefits last over a year. The trial will include children between about 3 and 11 years old who have been diagnosed with growth hormone deficiency based on their growth patterns and hormone tests.

If your child joins the study, they will be randomly assigned to receive either GB08 or Norditropin. In the first part of the study, they will get one of three doses of GB08 or the standard treatment for 24 weeks, with doctors closely monitoring their growth and safety. In the second part, the best GB08 dose will be compared to the standard treatment for up to 52 weeks to see how well it works over a longer time. The study will involve regular visits for growth measurements and health checks. Families should know that the trial is not yet recruiting, and there are specific health rules to ensure safety, such as excluding children with certain other conditions or past treatments. Participation requires informed consent from parents or guardians, and from the child if they are old enough to understand.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Diagnosed with Growth Hormone Deficiency (GHD) based on medical history, clinical symptoms and signs, GH stimulation tests, and imaging studies. The participant must meet the following:
• • 1. Absolute height 2 standard deviations (SD) below the mean height of children of the same age and sex, according to the standardized growth curves for children and adolescents in China (0-18 years old) published in 2009.
• • 2. Annualized height velocity (AHV) ≤ 5.0 cm/year, calculated from measurement of 6 to 18 months before screening.
• • 3. GH peak ≤ 10 ng/ml proved by two different GH stimulation tests within a year before screening.
• • 4. Bone age lagging at least 1 year behind actual age (bone age assessment within the past 6 months before screening), with girls \< 10 years old and boys \< 11 years old.
• • 2. Aging \> 3 years and ≤ 10 years (girls) or ≤ 11 years (boys) based on birth date; Tanner stage I (testicular volume \< 4 ml for boys and no palpable breast tissue for girls) 3. Uniform short stature with normal intellectual development. 4. IGF-1 levels below the mean for children and adolescents of the same age and sex, at least 1 SD below (IGF-1 SDS ≤ -1.0).
• • 5. Body mass index (BMI) within ±2 SD of the mean BMI for children and adolescents of the same age and sex.
• • 6. For subjects with GHD as part of multiple pituitary hormone deficiencies, must be stable for ≥1 month, as determined by the investigator.
• • 7. Guardians understand and sign the Informed Consent Form (ICF). If the participant is ≥8 years old, they must also sign the ICF. For participants \<8 years old who can express consent, their consent must be recorded.
• Exclusion Criteria:
• • 1. History of systematic growth-promoting therapy, including growth hormone and sex hormones.
• • 2. Severe allergic constitution or known allergy to growth hormone or its excipients, such as mannitol, lysine, or sodium chloride.
• • 3. Closed epiphyses.
• • 4. Other types of growth disorders such as idiopathic short stature, Turner syndrome, Noonan syndrome, Prader-Willi syndrome, and Russell-Silver syndrome.
• • 5. Short stature due to other causes, such as intrauterine growth restriction, familial short stature, thyroid hormone deficiency, adrenal insufficiency, antidiuretic hormone deficiency, celiac disease, rickets, psychological factors, chronic kidney disease, infections, or trauma.
• • 6. Any clinically significant abnormalities that may affect growth or growth assessment; subjects with liver or kidney dysfunction (ALT \> 1.5 times upper limit of normal, creatinine \> upper limit of normal), chronic diseases (malnutrition, fasting blood glucose ≥ 126 mg/dL or HbA1c ≥ 6.5%), diabetes, severe cardiac, pulmonary, hematological, or systemic infections, immunodeficiency, psychiatric disorders, or congenital malformations.
• • 7. Infectious diseases, such as hepatitis B, hepatitis C, AIDS, syphilis, or tuberculosis (HBV surface antigen-positive subjects must undergo HBV DNA testing; HCV antibody-positive subjects must undergo HCV RNA testing; if HBV DNA or HCV RNA \> detection limit, they are excluded).
• • 8. Use of corticosteroids or other steroids within the past 12 months, such as long-term steroid use for asthma.
• • 9. History of pituitary or hypothalamic tumors, or other intracranial tumors on MRI; history of leukemia, lymphoma, or other malignancies.
• • 10. History of radiation therapy or chemotherapy.
• • 11. Congenital intracranial hypertension.
• • 12. Femoral head slipped epiphysis (SCFE).
• • 13. Spinal scoliosis \> 15°.
• • 14. Participation in any other drug clinical trial within the past 3 months (as a subject).
• • 15. Other factors deemed unsuitable for participation in the study by the investigator.