Healthy VolunteersPhase 1NCT06743997
A Study to Compare Eutropin Formulations in Healthy Volunteers for Bioavailability, Safety, and Tolerability
A Phase 1 study testing Test Drug (Eutropin Catridge, 48IU/Cartridge) and Reference Drug (Eutropin, 4 IU/vial) in people with Healthy Volunteers, run by LG Chem at 1 site in South Korea.
Trial summary
A randomized, Open Label, Single Subcutaneous Dose, 2x2 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Test Drug (Eutropin Catridge, 48IU/Cartridge) and Reference Drug (Eutropin, 4 IU/vial)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jan 2025to 15 Apr 2025
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 19 to 40years at screening.
- Voluntarily decide to participate and provide written informed consent.
- Able to receive the investigational product (IP) and pre-treatment drugs.
- Wiliing and able to comply with study requirements, including follow-up visits and blood/urine sampling.
Who cannot join
- History of conditions contraindicating somatropin or pre-treatment drugs.
- Clinically significant medical history.
- Participation in another clinical trial and receipt of an investigational product within 80 days prior to the first IP administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Single Subcutaneous Dose, 2x2 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers
A randomized, Open Label, Single Subcutaneous Dose, 2x2 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in Healthy Volunteers
- Conditions
- Healthy Volunteers
- Being tested
- Test Drug (Eutropin Catridge, 48IU/Cartridge), Reference Drug (Eutropin, 4 IU/vial)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Drug (Eutropin Catridge, 48IU/Cartridge)Drug
Also called T, Test Drug
Liqid somatropin
Reference Drug (Eutropin, 4 IU/vial)Drug
Also called R, Reference Drug
Lyophilized somatropin
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants receive a single subcutaneous dose of the Test Drug(T), in the first period, followed by a washout period, and then a single subcutaneous dose of the Reference Drug(R) in the second period. Receives: Drug: Test Drug (Eutropin Catridge, 48IU/Cartridge); Drug: Reference Drug (Eutropin, 4 IU/vial) |
| Sequence 2 | Experimental | Participants receive a single subcutaneous dose of the Reference Drug(R), in the first period, followed by a washout period, and then a single subcutaneous dose of the Test Drug(T) in the second period. Receives: Drug: Test Drug (Eutropin Catridge, 48IU/Cartridge); Drug: Reference Drug (Eutropin, 4 IU/vial) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of somatropin
AUClast will be used to evaluate the pharmacokinetics of somatropin
Measured: 0 to 24 hours post-dose
Secondary outcomes (6)
AUCinf of somatropin
AUCinf will be used to evaluate the pharmacokinetics of somatropin.
Measured: 0 to 24 hours post-dose
Cmax of somatropin
Cmax will be used to evaluate the pharmacokinetics of somatropin.
Measured: 0 to 24 hours post-dose
Tmax of soatropin
Tmax will be used to evaluate the pharmacokinetics of somatropin.
Measured: 0 to 24 hours post-dose
T1/2β of somatropin
T1/2β will be used to evaluate the pharmacokinetics of somatropin.
Measured: 0 to 24 hours post-dose
Change in IGF-1 levels
Change in IGF-1 levels will be used to evaluate the parmacodynamic effect of somatropin.
Measured: 0 to 24 hours post-dose
Change in IGFBP-3 levels
Change in IGFBP-3 levels will be used to evaluate the parmacodynamic effect of somatropin.
Measured: 0 to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start13 Jan 2025
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743997
- Sponsor's protocol ID
- LG-HGCL011
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 17 Apr 2025
- 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 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Subcutaneous Dose, 2x2 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06743997
- Acronym / sponsor ID
- LG-HGCL011
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 20 Dec 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.
A randomized, Open Label, Single Subcutaneous Dose, 2x2 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in Healthy Volunteers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Test Drug (Eutropin Catridge, 48IU/Cartridge), Drug: Reference Drug (Eutropin, 4 IU/vial)Participants receive a single subcutaneous dose of the Test Drug(T), in the first period, followed by a washout period, and then a single subcutaneous dose of the Reference Drug(R) in the second period. |
| Sequence 2 | Experimental | Drug: Test Drug (Eutropin Catridge, 48IU/Cartridge), Drug: Reference Drug (Eutropin, 4 IU/vial)Participants receive a single subcutaneous dose of the Reference Drug(R), in the first period, followed by a washout period, and then a single subcutaneous dose of the Test Drug(T) in the second period. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults aged 19 to 40years at screening.
- Voluntarily decide to participate and provide written informed consent.
- Able to receive the investigational product (IP) and pre-treatment drugs.
- Wiliing and able to comply with study requirements, including follow-up visits and blood/urine sampling.
Key exclusion criteria (3 listed)
- History of conditions contraindicating somatropin or pre-treatment drugs.
- Clinically significant medical history.
- Participation in another clinical trial and receipt of an investigational product within 80 days prior to the first IP administration.
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 |
|---|---|---|
| Test Drug (Eutropin Catridge, 48IU/Cartridge)Also: T, Test DrugLiqid somatropin | Drug | Sequence 1, Sequence 2 |
| Reference Drug (Eutropin, 4 IU/vial)Also: R, Reference DrugLyophilized somatropin | Drug | Sequence 1, Sequence 2 |
Primary outcome
AUClast of somatropin
Time frame: 0 to 24 hours post-dose
AUClast will be used to evaluate the pharmacokinetics of somatropin
6 secondary outcomes
AUCinf of somatropin
Time frame: 0 to 24 hours post-dose
Cmax of somatropin
Time frame: 0 to 24 hours post-dose
Tmax of soatropin
Time frame: 0 to 24 hours post-dose
T1/2β of somatropin
Time frame: 0 to 24 hours post-dose
Change in IGF-1 levels
Time frame: 0 to 24 hours post-dose
Change in IGFBP-3 levels
Time frame: 0 to 24 hours post-dose
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 17 Apr 2025.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 Test Drug (Eutropin Catridge, 48IU/Cartridge) and Reference Drug (Eutropin, 4 IU/vial) in people with Healthy Volunteers, run by LG Chem 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 4 inclusion and 3 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 17 Apr 2025. 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?
AUClast of somatropin (time frame: 0 to 24 hours post-dose). 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 17 Apr 2025.