A Bioequivalence Study of Two Different PEG-rhGH Preparations

GeneScience Pharmaceuticals (GenSci)

Status and phase: Completed; Phase 1

Conditions: Pediatric Growth Hormone Deficiency (PGHD)

Treatments: Drug: PEG-rhGH with present preparation (T); Drug: PEG-rhGH with new preparation (T)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06797505

GenSci004-112

Details and patient eligibility

About

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

Full description

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

Enrollment: 87 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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87 participants in 3 patient groups

T-R-R

Experimental group

Description:

Administration order: PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R)

Treatment:

Drug: PEG-rhGH with new preparation (T)

Drug: PEG-rhGH with present preparation (T)

R-T-R

Experimental group

Description:

Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R)

Treatment:

Drug: PEG-rhGH with new preparation (T)

Drug: PEG-rhGH with present preparation (T)

R-R-T

Experimental group

Description:

Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T)

Treatment:

Drug: PEG-rhGH with new preparation (T)

Drug: PEG-rhGH with present preparation (T)