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Not yet recruiting NCT06840691

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

Phase I Interventional Pediatric Growth Hormone Deficiency (PGHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (T).
Who it may be relevant to
Registry conditions: Pediatric Growth Hormone Deficiency (PGHD). Basic parameters: 18 years — 45 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Detailed description

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

Interventions

  • Drug PEG-rhGH with new preparation (T)
    A single subcutaneous injection of PEG-rhGH with new preparation
  • Drug PEG-rhGH with present preparation (T)
    A single subcutaneous injection of PEG-rhGH with present preparation

Primary outcome measures

  • Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation [Time frame: 0 hours -408 hours post-administration]
  • Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation [Time frame: 0 hours -408 hours post-administration]
  • Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0- last )) of PEG-rhGH with present and new preparation [Time frame: 0 hours -408 hours post-administration]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

China · 1 center
  • Chengdu Xinhua Hospital — Chengdu

Identifiers

NCT: NCT06840691 · GenSci034-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗