Pediatric Growth Hormone Deficiency (PGHD)Phase 1NCT06840691
A Bioequivalence Study of Two Different Processes of PEG-rhGH Preparations
A Phase 1 study testing PEG-rhGH with new preparation (T) and PEG-rhGH with present preparation (T) in people with Pediatric Growth Hormone Deficiency (PGHD), run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pediatric Growth Hormone Deficiency (PGHD)
- What is being tested?
- PEG-rhGH with new preparation (T) and PEG-rhGH with present preparation (T)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- May 2025to Sep 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chengdu Xinhua Hospital
Chengdu, Sichuan, 610000
Xiaolan Yong, Doctor, +86-28-60212136, yongxlan@126.com
About this study
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
The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.
Read the detailed description
The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.
- Being tested
- PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (T)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhGH with new preparation (T)Drug
A single subcutaneous injection of PEG-rhGH with new preparation
PEG-rhGH with present preparation (T)Drug
A single subcutaneous injection of PEG-rhGH with present preparation
| Study group | Role | What they receive |
|---|---|---|
| T-R-R | Experimental | Administration order: PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R) Receives: Drug: PEG-rhGH with new preparation (T); Drug: PEG-rhGH with present preparation (T) |
| R-T-R | Experimental | Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R) Receives: Drug: PEG-rhGH with new preparation (T); Drug: PEG-rhGH with present preparation (T) |
| R-R-T | Experimental | Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T) Receives: Drug: PEG-rhGH with new preparation (T); Drug: PEG-rhGH with present preparation (T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation
Measured: 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
Measured: 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
Measured: 0 hours -408 hours post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Growth Hormone Deficiency (PGHD)Studies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840691
- Sponsor's protocol ID
- GenSci034-102
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No