Growth Hormone DeficiencyPhase 1HL-032NCT01440686
Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers
A Phase 1 study testing Somatropin in people with Growth Hormone Deficiency, run by HanAll BioPharma Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of HL-032 after oral administration in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Somatropin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Jan 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 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects
- Age(yr)between 19 and 50
- Signed written informed consent
Who cannot join
- Known hypersensitivity to Octreotide or hGH(human growth hormone)
- History of Cardiovascular, Respiratory, Renal/Genitourinary, Gastrointestinal, Neurological/Psychic, cancer
- Alcoholic, smokers or drug abusers
- Other conditions which in the opinion of the investigator preclude enrollment into the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
Seoul, 110-744
About this study
Official title: A Dose Block-randomized, Double-blinded, Placebo-controlled, Single-dose, Dose-escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of HL-032 in Healthy Male Volunteers
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of HL-032 after oral administration in healthy male volunteers.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Somatropin, Placebo
- Keywords
- Pharmacokinetics, Pharmacodynamics, Safety, Male
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
PlaceboDrug
Tablets, oral administrations
| Study group | Role | What they receive |
|---|---|---|
| HL-032 30mg | Experimental | A single dose 30mg administered orally Receives: Drug: Somatropin; Drug: Placebo |
| HL-032 60mg | Experimental | A single dose 60mg administered orally Receives: Drug: Somatropin; Drug: Placebo |
| HL-032 120mg | Experimental | A single dose 120mg administered orally Receives: Drug: Somatropin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum hGH(human growth hormone)concentration-time curve
Measured: From 0 to the time of the last quantifiable concentration over a 32-hour sampling period
Maximum observed serum hGH concentration
Measured: Over a 32-hour sampling period
Secondary outcomes (2)
Area under the effect(IGF-1, IGFBP-3, NEFA)curve
Measured: From time 0 to the time of the last concentration(AUECO-t) over 32-hour sampling period
Maximum IGF-1, IGFBP-3, NEFA effect
Measured: Over a 32-hour sampling period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HanAll BioPharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, Medicine, Principal investigator, Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440686
- Sponsor's protocol ID
- HGR10I_1
- Acronym
- HL-032
- Status last verified
- Oct 2012
- First submitted
- 23 Sep 2011
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Block-randomized, Double-blinded, Placebo-controlled, Single-dose, Dose-escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of HL-032 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01440686
- Acronym / sponsor ID
- HL-032 / HGR10I_1
- Conditions
- Growth Hormone Deficiency
- Keywords
- Pharmacokinetics, Pharmacodynamics, Safety, Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- HanAll BioPharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Sep 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.
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of HL-032 after oral administration in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HL-032 30mg | Experimental | Drug: Somatropin, Drug: PlaceboA single dose 30mg administered orally |
| HL-032 60mg | Experimental | Drug: Somatropin, Drug: PlaceboA single dose 60mg administered orally |
| HL-032 120mg | Experimental | Drug: Somatropin, Drug: PlaceboA single dose 120mg administered orally |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects
- Age(yr)between 19 and 50
- Signed written informed consent
Key exclusion criteria (4 listed)
- Known hypersensitivity to Octreotide or hGH(human growth hormone)
- History of Cardiovascular, Respiratory, Renal/Genitourinary, Gastrointestinal, Neurological/Psychic, cancer
- Alcoholic, smokers or drug abusers
- Other conditions which in the opinion of the investigator preclude enrollment into the study
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 |
|---|---|---|
| SomatropinA single dose 5.0mg administered subcutaneously(under the skin) via Genotropin | Drug | HL-032 120mg, HL-032 30mg, HL-032 60mg |
| PlaceboTablets, oral administrations | Drug | HL-032 120mg, HL-032 30mg, HL-032 60mg |
Primary outcome
Area under the serum hGH(human growth hormone)concentration-time curve
Time frame: From 0 to the time of the last quantifiable concentration over a 32-hour sampling period
Maximum observed serum hGH concentration
Time frame: Over a 32-hour sampling period
2 secondary outcomes
Area under the effect(IGF-1, IGFBP-3, NEFA)curve
Time frame: From time 0 to the time of the last concentration(AUECO-t) over 32-hour sampling period
Maximum IGF-1, IGFBP-3, NEFA effect
Time frame: Over a 32-hour sampling period
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 16 Oct 2012.
Related trials for Growth Hormone Deficiency
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
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.
Kyung-Sang Yu, Medicine principal investigator
Seoul National University Hospital,Clinical Trial Center/ Clinical Research Institute
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 Somatropin in people with Growth Hormone Deficiency, run by HanAll BioPharma Co., Ltd. at 1 site in South Korea.
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 4 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 16 Oct 2012. 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 South Korea. 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?
Area under the serum hGH(human growth hormone)concentration-time curve (time frame: From 0 to the time of the last quantifiable concentration over a 32-hour sampling period). The study lists 2 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 16 Oct 2012.