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Completed

NCT Number: NCT06331026

A Bioequivalence Study of Two Different PEG-rhGH Preparations.

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

Completed

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chengdu Xinhua Hospital

Chengdu, Sichuan, 610000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;
  • 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 other diseases deemed unsuitable for participation in the trials by the investigators;
  • Subjects with severe infection, severe trauma, or major surgery prior to screening;
  • Subjects who have received blood transfusions, had blood donors, or lost blood before screening;
  • 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 prior to screening;etc.

Treatment and study plan

PEG-rhGH with new preparation (T)

Drug

A single subcutaneous injection of PEG-rhGH with new preparation

PEG-rhGH with present preparation (R)

Drug

A single subcutaneous injection of PEG-rhGH with present preparation

Primary outcomes

  1. Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation

    Time frame: 0 hours -192 hours post-administration

  2. 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 -192 hours post-administration

  3. 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 -192hours post-administration

Secondary outcomes

  1. Safety and tolerability(Number of participants with treatment-related adverse events)

    Time frame: up to approximately 83 days

Other outcomes

  1. Anti-drug antibody (Number of Participants with positive ADA)

    Time frame: 0 hours -192 hours post-administration

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-lable, Single-dose, 3-sequence, 3-period Crossover Bioequivalence Study of Two Different PEG-rhGH Preparations in Chinese Healthy Adults

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 26, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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