Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency

Inclusion Criteria:

• Prepubertal children with GHD in Tanner stage 1, aged of 3 years and below 17 years;

• Impaired HT defined as at least 2.0 standard deviations (SD) below the mean height forchronological age and sex (HT SDS≤-2.0) according to the Chinese 2005 standard；

• Diagnosis of GHD confirmed by 2 different GH stimulation tests, defined as a peak GHlevel of ≤10 ng/mL, determined with a validated assay. Bone age (BA) at least 6 monthsless than the chronological age；

• Baseline IGF-1 level of at least 1.0 SD below the mean IGF-1 level standardized forage and sex (IGF-1 SDS ≤-1.0)；

• Written, signed informed consent of the parent(s) or legal guardian(s) of the subjectand written assent of the subject (if the subject is 8 years old or above).

Exclusion Criteria:

• Children with a body weight below 12 kg；

• Prior exposure to recombinant hGH or IGF-1 therapy；

• Children with past or present intracranial tumor growth as confirmed by a sellar MRIscan (with contrast dye recommended) at Screening

• Children born SGA (birth weight ≤10th percentile for gestational age according to theChinese reference)；

• Children with psychosocial dwarfism；

• Children with idiopathic short stature；

• Other causes of short stature such as coeliac disease, hypothyroidism, or rickets；

• History or presence of malignant disease; any evidence of present tumor growth;

• Subjects with diabetes mellitus；

• Closed epiphyses；

• Major medical conditions and/or presence of contraindication to hGH treatment；

• Participation in any other trial of an investigational agent within 3 months prior toScreening.