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NCT06840691 | NOT YET RECRUITING | Pediatric Growth Hormone Deficiency (PGHD)

A Bioequivalence Study of Two Different Processes of PEG-rhGH Preparations
Sponsor:

Changchun GeneScience Pharmaceutical Co., Ltd.

Brief Summary:

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.

Condition or disease

Pediatric Growth Hormone Deficiency (PGHD)

Intervention/treatment

PEG-rhGH with new preparation (T)

PEG-rhGH with present preparation (T)

Phase

PHASE1

Detailed Description:

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.

Study Type : INTERVENTIONAL
Estimated Enrollment : 87 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : A Randomized, Open-lable, Single-dose, 3-sequence, 3-period Crossover Bioequivalence Study of Two Different PEG-rhGH （2mg/mL）Preparations in Chinese Healthy Adults
Actual Study Start Date : 2025-05
Estimated Primary Completion Date : 2025-05
Estimated Study Completion Date : 2025-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Healthy male aged ≥18 years old and≤45 years old;
  • * The Body mass index (BMI): 19-26 kg/m2 (inclusive), and body weight ≥50 kg;
  • * Normal results of physical examination, vital signs, laboratory tests, 12 lead-ECG, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.
Exclusion Criteria
  • * Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing; or a history of allergic diseases (including but not limited to asthma, urticaria, etc.), or allergic constitution (such as known allergy to two or more substances)
  • * Subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or suggest potential diseases, such as abnormal laboratory test results of liver and kidney function (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] exceeding the upper limit of normal, or total bilirubin exceeding the upper limit of normal; Or blood creatinine exceeding the upper limit of normal value); Or other diseases (such as a history of mental illness) deemed unsuitable for participation in the trials by the investigators;
  • * Subjects with severe infection, severe trauma, or major surgery within 6 months prior to screening;
  • * Subjects who have received blood transfusions, had blood donors, or lost blood ≥400 mL within 3 months before screening; Or plan to donate blood within 1 month of the end of the trial;
  • * Subjects who have positive results of human immunodeficiency virus antibodies (HIV-Ab), or hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab), or syphilis specific antibodies (TPPA);
  • * Subjects who have participated in clinical trials for medication or medical device within 3 months prior to screening;etc.
A Bioequivalence Study of Two Different Processes of PEG-rhGH Preparations

Location Details

NCT06840691

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How to Participate

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Locations

Not yet recruiting

China, Sichuan

Chengdu Xinhua Hospital

Chengdu, Sichuan, China, 610000