Pediatric Growth Hormone Deficiency (PGHD)Phase 1NCT06331026
A Bioequivalence Study of Two Different PEG-rhGH Preparations.
A Phase 1 study testing PEG-rhGH with new preparation (T) and PEG-rhGH with present preparation (R) 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 (R)
- 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
- 9 Apr 2024to 28 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-lable, Single-dose, 3-sequence, 3-period Crossover Bioequivalence Study of Two Different PEG-rhGH 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.
- Being tested
- PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R)
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 (R)Drug
A single subcutaneous injection of PEG-rhGH with present preparation
| Study group | Role | What they receive |
|---|---|---|
| TRR | 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 (R) |
| RTR | 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 (R) |
| RRT | 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 (R) |
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 -192 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 -192 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 -192hours post-administration
Secondary outcomes (1)
Safety and tolerability（Number of participants with treatment-related adverse events）
Measured: up to approximately 83 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start9 Apr 2024
- Primary completion15 Jul 2024
- Study completion28 Aug 2024
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 (actual)
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
- NCT06331026
- Sponsor's protocol ID
- GenSci004-106
- Status last verified
- Nov 2024
- First submitted
- 17 Mar 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-lable, Single-dose, 3-sequence, 3-period Crossover Bioequivalence Study of Two Different PEG-rhGH Preparations in Chinese Healthy Adults
- ClinicalTrials.gov ID
- NCT06331026
- Acronym / sponsor ID
- GenSci004-106
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRR | Experimental | Drug: PEG-rhGH with new preparation (T), Drug: PEG-rhGH with present preparation (R)Administration order: PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R) |
| RTR | Experimental | Drug: PEG-rhGH with new preparation (T), Drug: PEG-rhGH with present preparation (R)Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R) |
| RRT | Experimental | Drug: PEG-rhGH with new preparation (T), Drug: PEG-rhGH with present preparation (R)Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-rhGH with new preparation (T)A single subcutaneous injection of PEG-rhGH with new preparation | Drug | RRT, RTR, TRR |
| PEG-rhGH with present preparation (R)A single subcutaneous injection of PEG-rhGH with present preparation | Drug | RRT, RTR, TRR |
Primary outcome
Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation
Time frame: 0 hours -192 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 -192 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 -192hours post-administration
1 secondary outcome
Safety and tolerability（Number of participants with treatment-related adverse events）
Time frame: up to approximately 83 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEG-rhGH with new preparation (T) and PEG-rhGH with present preparation (R) in people with Pediatric Growth Hormone Deficiency (PGHD), run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation (time frame: 0 hours -192 hours post-administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.