HealthyPhase 1SomatropinNCT01339182
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers
A Phase 1 study testing Pegylated-Somatropin and YPEG-Somatropin in people with Healthy, run by Xiamen Amoytop Biotech Co., Ltd. at 1 site in China.
Trial summary
This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific data for the design and conduct of subsequent studies. 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
- Healthy
- What is being tested?
- Pegylated-Somatropin and YPEG-Somatropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Aug 2012
- 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 subjects
- Age(yr)between 18 and 45
- Body mass index(BMI)between 20 and 28
- sign informed consent
Who cannot join
- Known hypersensitivity to somatropin or any other components of the study drug
- Organic lesion in heart, liver, kidney or any other major organs
- History of diabetes mellitus, cancer, autoimmune disease, genetic disease, mental disease
- Alcoholic, smokers or drug abusers
- Blood donation, or massive blood loss due to injury or surgery within 3 months
- Other conditions which in the opinion of the investigator preclude enrollment into the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
About this study
Official title: A Randomized, Open-label, Single-dose, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated-Somatropin in Healthy Volunteers
This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific data for the design and conduct of subsequent studies.
- Conditions
- Healthy
- Being tested
- Pegylated-Somatropin, YPEG-Somatropin
- Keywords
- somatropin, PK, PD, male, pharmacokinetics, pharmacodynamics, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated-SomatropinDrug
Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-Somatropin, 10mcg/kg.
YPEG-SomatropinDrug
Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 30mcg/kg.
YPEG-SomatropinDrug
Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 60mcg/kg.
YPEG-SomatropinDrug
Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 120mcg/kg.
YPEG-SomatropinDrug
Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 200mcg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Pegylated-Somatropin, 10mcg/kg | Experimental | Not described Receives: Drug: Pegylated-Somatropin |
| Pegylated-Somatropin, 30mcg/kg | Experimental | Not described Receives: Drug: YPEG-Somatropin |
| Pegylated-Somatropin, 60mcg/kg | Experimental | Not described Receives: Drug: YPEG-Somatropin |
| Pegylated-Somatropin, 120mcg/kg | Experimental | Not described Receives: Drug: YPEG-Somatropin |
| Pegylated-Somatropin, 200mcg/kg | Experimental | Not described Receives: Drug: YPEG-Somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the IGF-1 levels for pharmacodynamics study
Measured: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug
Secondary outcomes (2)
Measuring the drug levels in blood samples
Measured: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug
Measurement of IGFBP-3 levels for pharmacodynamic study
Measured: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Xiamen Amoytop Biotech 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Sponsor
- Investigators
- Hu Pei, Ph.D, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339182
- Sponsor's protocol ID
- TB1010GH
- Acronym
- Somatropin
- Status last verified
- Dec 2010
- First submitted
- 14 Apr 2011
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated-Somatropin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01339182
- Acronym / sponsor ID
- Somatropin / TB1010GH
- Conditions
- Healthy
- Keywords
- somatropin, PK, PD, male, pharmacokinetics, pharmacodynamics, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital
- Study start
- Jan 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Apr 2011 (estimated)
- 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.
This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific data for the design and conduct of subsequent studies.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pegylated-Somatropin, 10mcg/kg | Experimental | Drug: Pegylated-Somatropin |
| Pegylated-Somatropin, 30mcg/kg | Experimental | Drug: YPEG-Somatropin |
| Pegylated-Somatropin, 60mcg/kg | Experimental | Drug: YPEG-Somatropin |
| Pegylated-Somatropin, 120mcg/kg | Experimental | Drug: YPEG-Somatropin |
| Pegylated-Somatropin, 200mcg/kg | Experimental | Drug: YPEG-Somatropin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects
- Age(yr)between 18 and 45
- Body mass index(BMI)between 20 and 28
- sign informed consent
Key exclusion criteria (6 listed)
- Known hypersensitivity to somatropin or any other components of the study drug
- Organic lesion in heart, liver, kidney or any other major organs
- History of diabetes mellitus, cancer, autoimmune disease, genetic disease, mental disease
- Alcoholic, smokers or drug abusers
- Blood donation, or massive blood loss due to injury or surgery within 3 months
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 |
|---|---|---|
| Pegylated-SomatropinDaily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-Somatropin, 10mcg/kg. | Drug | Pegylated-Somatropin, 10mcg/kg |
| YPEG-SomatropinDaily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 30mcg/kg. | Drug | Pegylated-Somatropin, 30mcg/kg |
| YPEG-SomatropinDaily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 60mcg/kg. | Drug | Pegylated-Somatropin, 60mcg/kg |
| YPEG-SomatropinDaily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 120mcg/kg. | Drug | Pegylated-Somatropin, 120mcg/kg |
| YPEG-SomatropinDaily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 200mcg/kg. | Drug | Pegylated-Somatropin, 200mcg/kg |
Primary outcome
Measurement of the IGF-1 levels for pharmacodynamics study
Time frame: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug
2 secondary outcomes
Measuring the drug levels in blood samples
Time frame: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug
Measurement of IGFBP-3 levels for pharmacodynamic study
Time frame: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug
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 4 Feb 2013.
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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.
Hu Pei, Ph.D principal investigator
Peking Union Medical College Hospital
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 Pegylated-Somatropin and YPEG-Somatropin in people with Healthy, run by Xiamen Amoytop Biotech 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 4 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 4 Feb 2013. 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?
Measurement of the IGF-1 levels for pharmacodynamics study (time frame: baseline, one week after initiation of the control drug and two weeks after initiation of the study drug). 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 4 Feb 2013.