HealthyPhase 1hGHNCT02146625
Safety, Tolerability, PK, PD, ADA of Escalating Single Dose of CJ-40002 in Healthy Male Subjects
A Phase 1 study testing CJ-40002 in people with Healthy, run by HK inno.N Corporation.
Trial summary
The objectives of this study are: To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy male volunteers. To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers. To evaluate the PD of CJ-40002 after single SC injection in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CJ-40002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Sep 2015
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers in the age between 19 and 45 years old (inclusive)
- Body mass index (BMI) in the range of 18.5 to 25 kg/m2 and weighing at least 55 kg
- Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form, after having listened to the purpose, method, and effect of the clinical trial
Who cannot join
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition
- History of allergy or sensitivity to any drug
- Subject with the following clinically significant laboratory abnormalities:
- AST or ALT > 1.25 x Upper Limit Normal (ULN)
- Total bilirubin > 1.5 x Upper Limit Normal (ULN)
- CPK > 1.5 x Upper Limit Normal (ULN)
Show all 14Show fewer
- eGFR < 60 mL/min/1.73 m2
- Systolic blood pressure outside the range of 90 to 150 mmHg or diastolic blood pressure outside the range of 50 to 100 mmHg
- History of drug abuse
- History of caffeine, alcohol, smoking abuse
- Participation in any clinical investigation within 60days prior to study medication dosing
- Subjects with whole blood donation within 60days, component blood donation within 30days prior to study medication dosing
- Positive test results for HBs Ab, HCV Ab, HIV test
- Subjects considered as unsuitable based on medical judgement by investigators
About this study
Official title: A Dose-block Randomized, Single-blind, Placebo-controlled, Single-dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CJ-40002 After Subcutaneous Injection in Healthy Adult Male Volunteers
The objectives of this study are:
- To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy male volunteers.
- To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers.
- To evaluate the PD of CJ-40002 after single SC injection in healthy male volunteers.
- To evaluate the ADA of CJ-40002 after single SC injection in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- CJ-40002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-40002Drug
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 of CJ-40002 | Experimental | * Single dose
* 8 volunteers will be administered dose level 1 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) Receives: Drug: CJ-40002 |
| Dose level 2 of CJ-40002 | Experimental | * Single dose
* 8 volunteers will be administered dose level 2 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) Receives: Drug: CJ-40002 |
| Dose level 3 of CJ-40002 | Experimental | * Single dose
* 8 volunteers will be administered dose level 3 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) Receives: Drug: CJ-40002 |
| Dose level 4 of CJ-40002 | Experimental | * Single dose
* 8 volunteers will be administered dose level 4 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) Receives: Drug: CJ-40002 |
| Dose level 5 of CJ-40002 | Experimental | * Single dose
* 8 volunteers will be administered dose level 5 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) Receives: Drug: CJ-40002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: AUC, Cmax
Measured: 15 days
Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction)
Measured: 29 days
Secondary outcomes (3)
Pharmacokinetics: Tmax, T1/2, CL/F, Vd
Measured: 15 days
Pharmacodynamics: Serum IGF-1, free IGF-1, IGFBP-3, GHBP
Measured: 15 days
Formation of anti-drug antibodies
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionSep 2015
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 HK inno.N CorporationThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Soo Park, MD, PhD, Principal investigator, Yonsei University College of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146625
- Sponsor's protocol ID
- CJ_HGH_101
- Acronym
- hGH
- Status last verified
- Dec 2016
- First submitted
- 19 May 2014
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-block Randomized, Single-blind, Placebo-controlled, Single-dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of CJ-40002 After Subcutaneous Injection in Healthy Adult Male Volunteers
- ClinicalTrials.gov ID
- NCT02146625
- Acronym / sponsor ID
- hGH / CJ_HGH_101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 May 2014 (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 objectives of this study are:
- To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy male volunteers.
- To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers.
- To evaluate the PD of CJ-40002 after single SC injection in healthy male volunteers.
- To evaluate the ADA of CJ-40002 after single SC injection in healthy male volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 of CJ-40002 | Experimental | Drug: CJ-40002* Single dose * 8 volunteers will be administered dose level 1 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) |
| Dose level 2 of CJ-40002 | Experimental | Drug: CJ-40002* Single dose * 8 volunteers will be administered dose level 2 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) |
| Dose level 3 of CJ-40002 | Experimental | Drug: CJ-40002* Single dose * 8 volunteers will be administered dose level 3 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) |
| Dose level 4 of CJ-40002 | Experimental | Drug: CJ-40002* Single dose * 8 volunteers will be administered dose level 4 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) |
| Dose level 5 of CJ-40002 | Experimental | Drug: CJ-40002* Single dose * 8 volunteers will be administered dose level 5 of CJ-40002 or placebo comparators.(CJ-40002:placebo=6:2) |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers in the age between 19 and 45 years old (inclusive)
- Body mass index (BMI) in the range of 18.5 to 25 kg/m2 and weighing at least 55 kg
- Subject who have voluntarily agreed to participate in the trial and signed the written informed consent form, after having listened to the purpose, method, and effect of the clinical trial
Key exclusion criteria (14 listed)
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition
- History of allergy or sensitivity to any drug
- Subject with the following clinically significant laboratory abnormalities:
- Systolic blood pressure outside the range of 90 to 150 mmHg or diastolic blood pressure outside the range of 50 to 100 mmHg
- History of drug abuse
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 |
|---|---|---|
| CJ-40002 | Drug | Dose level 1 of CJ-40002, Dose level 2 of CJ-40002, Dose level 3 of CJ-40002, Dose level 4 of CJ-40002, Dose level 5 of CJ-40002 |
Primary outcome
Pharmacokinetics: AUC, Cmax
Time frame: 15 days
Safety and Tolerability (AE's, vital signs, ECG, laboratory tests, local reaction)
Time frame: 29 days
3 secondary outcomes
Pharmacokinetics: Tmax, T1/2, CL/F, Vd
Time frame: 15 days
Pharmacodynamics: Serum IGF-1, free IGF-1, IGFBP-3, GHBP
Time frame: 15 days
Formation of anti-drug antibodies
Time frame: 29 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 29 Dec 2016.
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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.
Min Soo Park, MD, PhD principal investigator
Yonsei University College of Medicine, Seoul, Korea
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CJ-40002 in people with Healthy, run by HK inno.N Corporation.
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 14 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 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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: AUC, Cmax (time frame: 15 days). 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 29 Dec 2016.