Healthy VolunteersPhase 1NCT02175056
A Dose-Block Randomized, Placebo Controlled (Double-blind), Active Controlled(Open-label), Dose-escalation Study
A Phase 1 study testing HL2351 and Kineret(Anakinra) in people with Healthy Volunteers, run by Handok Inc. at 1 site in South Korea.
Trial summary
The study design of this trial is a Dose-Block Randomized, Placebo controlled (Double-blind), Active Controlled(Open-label), Dose-escalation. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- HL2351 and Kineret(Anakinra)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Feb 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A healthy adult man aged between 20 and 45 years (inclusive) at screening
- Weight between 55 and 90 kg (inclusive) and the body mass index(BMI) between 18.0 and 27.0 (inclusive)
- BMI(kg/m2) = Body weight (kg)/{height (m)}2
- Voluntary consent to participation in this study and signature on the IRB-approved informed consent form after being explained about characteristics of this clinical study, prior to any screening test
Who cannot join
- Current or history of a clinically significant hepatic, renal, neurological, immunological, respiratory or endocrine disease or hematological or oncological disease, cardiovascular disease or psychiatric disease (mood disorder or compulsive disorder, etc.) (in case of a hepatic disease, a hepatitis virus-infected subject may be also included)
- Hypersensitivity to a drug (aspirin or antibiotics, etc.) or past history of clinically significant hypersensitivity
- In sitting vital signs measured after resting for 3 min or more, systolic blood pressure of <90mmHg or >150mmHg, or diastolic blood pressure of <60mmHg or >100 mmHg
- Past history of drug abuse or positive urine drug screening results
- Use of any prescription medicine or oriental medicine within 2 weeks or use of any over-the-counter(OTC) medication or vitamin preparation within 1 week prior to the scheduled first dose (however, a subject may be included if other conditions are satisfied, at the discretion of the investigator)
- Participation in another clinical study and administration of a drug within 3 months prior to the scheduled first dose (from the dosing day)
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- Whole blood donation within 2 months or apheresis within 1 month prior to the scheduled first dose, or transfusion within 1 month prior to the first dose
- A habitual drinker (>21 units/week, 1 unit = 10 g of pure alcohol) or a person who cannot abstain from alcohol consumption during hospitalization
- A smoker of 10 cigarettes/day on average over the past 3 months or a person who cannot abstain from smoking during hospitalization
- A person who is planning to get pregnant during the study or who cannot practice acceptable contraception (example: surgical sterilization of a subject or a partner, intrauterine device used by a partner, barrier contraception, diaphragm or condom used in combination) even if not planning to get pregnant
- Notable prolongation of the QT/QTcb interval at screening (e.g., repeated confirmation of QTcb interval > 450 ms)
- Confirmed history of a risk factor for TdP (e.g., heart failure, hypokalemia, family history of a long QT syndrome)
- Chronic, uncontrolled or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosis)
- Pyrexia of ≥38°C within 1 week prior to administration of the investigational product
- Past history of tuberculosis infection and/or positive Quantiferon TB-Gold test results at screening
- A person who had participated in this study and received the investigational product
- A person who is otherwise determined as not eligible for clinical study participation by the investigator due to other reasons including clinical laboratory test results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose-Block Randomized, Placebo Controlled (Double-blind), Active Controlled(Open-label), Dose-escalation Study to Investigate the Tolerability, and Pharmacokinetics/Pharmacodynamics of HL2351 After a Single Subcutaneous Administration in Healthy Male Subjects
The study design of this trial is a Dose-Block Randomized, Placebo controlled (Double-blind), Active Controlled(Open-label), Dose-escalation.
Read the detailed description
- Extended in vivo half-life of HL2351 is also anticipated to provide improved therapeutic efficacy based on sustained maintenance of an effective concentration.
- A safety concern may be addressed by utilizing IL-1Ra that is being used after getting approval by the EMA and the US FDA and known to be relatively safe, and the Fc fusion technology that has been already applied to various therapeutic agents.
- Conditions
- Healthy Volunteers
- Being tested
- HL2351, Kineret(Anakinra)
- Keywords
- First In Human, CAPS, SoJIA, AOSD, Bechet Disease, Rheumatoid arthritis
- Medical subject headings
- Cryopyrin-Associated Periodic Syndromes, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL2351Biological
Dose-escalation For 5 level dose groups A ~ E(each 1, 2, 4, 8, 12mg/kg), 10 subjects (8 for the study drug and 2 for placebo) are randomized to each dose group, and the study drug or placebo is subcutaneously administered for the relevant dose group.
Kineret(Anakinra)Biological
Active comparator(group F) is implemented in parallel with dose groups A~E in an open-label manner and 8 subjects subcutaneously administer Kineret® 100 mg.
| Study group | Role | What they receive |
|---|---|---|
| HL2351 | Experimental | 1, 2, 4, 8, 12 mg/kg (SC) / Single-Dose Receives: Biological: HL2351 |
| Placebo | Placebo comparator | 1, 2, 4, 8, 12 mg/kg (SC) / Single-Dose Receives: Biological: HL2351 |
| Kineret(Anakinra) | Active comparator | 100 mg (SC) / Single-Dose Receives: Biological: Kineret(Anakinra) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability as measured by the occurrence of Adverse Events
Adverse Events after single subcutaneous dose of HL2351
: check Day -1, 1, 2, 3, 4, 5, 7, 11, 15, 22, 29
Measured: 29 days
Tolerability as measured by Physical Examination, Vital Signs and Safety Laboratory Tests
Changes from baseline in physical examination, vital signs, ECG, clinical laboratory tests (routine hematology, routine chemistry, blood coagulation and urinalysis) after single subcutaneous dose of HL2351
Measured: 29 days
Tolerability as measured by the occurrence of Local Toxicity
Local Toxicity after single subcutaneous dose of HL2351
: check Day 1, 2, 4
Measured: 4 days
Tolerability as measured by Cytokine Laboratory Test
Cytokine Laboratory Test after single subcutaneous dose of HL2351
: check Day 1, 2, 4
Measured: 4 days
Pharmacokinetics of HL2351: Maximum plasma concentration(Cmax)
To assess pharmacokinetics after single subcutaneous injection of HL2351
Measured: 29 days
Pharmacokinetics of HL2351: Area under plasma drug concentration-time curve [AUC(0-last), AUCinf]
To assess pharmacokinetics after single subcutaneous injection of HL2351
Measured: 29 days
Pharmacokinetics of HL2351: Time of maximum concentration(Tmax)
To assess pharmacokinetics after single subcutaneous injection of HL2351
Measured: 29 days
Pharmacokinetics of HL2351: Elimination half-life(T1/2)
To assess pharmacokinetics after single subcutaneous injection of HL2351
Measured: 29 days
Pharmacokinetics of HL2351: Apparent Clearance(CL/F)
To assess pharmacokinetics after single subcutaneous injection of HL2351
Measured: 29 days
Pharmacokinetics of HL2351: Apparent Volume of Distribution(Vz/F)
To assess pharmacokinetics after single subcutaneous injection of HL2351
Measured: 29 days
Pharmacokinetics of HL2351: Mean Residence Time (MRT)
To assess pharmacokinetics after single subcutaneous injection of HL2351
Measured: 29 days
Pharmacodynamics of HL2351: IL-6 inhibition assay
To assess the pharmacodynamic dose-response relationship after single subcutaneous injection of HL2351 IL-6 inhibition assay: AUEClast, Emax
Measured: 7 days
Secondary outcomes (13)
Immunogenicity of HL2351: Anti-drug Antibody
To assess immunogenicity after single subcutaneous injection of HL2351
Measured: Day 1, Day 29
Tolerability in comparison with Kineret(Anakinra): measured by the occurrence of Adverse Events
To explore tolerability in comparison with subcutaneous administration of a positive comparator, Kineret(Anakinra)
Measured: 3 days
Tolerability in comparison with Kineret(Anakinra): measured by Physical Examination, Vital Signs and Safety Laboratory Tests
To explore tolerability in comparison with subcutaneous administration of a positive comparator, Kineret(Anakinra)
Measured: 3 days
Tolerability in comparison with Kineret(Anakinra): measured by the occurrence of Local Toxicity
To explore tolerability in comparison with subcutaneous administration of a positive comparator, Kineret(Anakinra)
Measured: 3 days
Tolerability in comparison with Kineret(Anakinra): measured by Cytokine Laboratory Test
To explore tolerability in comparison with subcutaneous administration of a positive comparator, Kineret(Anakinra)
Measured: 3 days
Pharmacokinetics in comparison with Kineret(Anakinra): Maximum plasma concentration
To explore pharmacokinetics in comparison with subcutaneous administration of a positive comparator, Kineret(Anakinra)
Measured: 3 days
Pharmacokinetics in comparison with Kineret(Anakinra): Area under plasma drug concentration-time curve [AUC(0-last), AUCinf]
To explore pharmacokinetics in comparison with subcutaneous administration of a positive comparator, Kineret(Anakinra)
Measured: 3 days
Pharmacokinetics in comparison with Kineret(Anakinra): Time of maximum concentration(Tmax)
To explore pharmacokinetics in comparison with subcutaneous administration of a positive comparator, Kineret(Anakinra)
Measured: 3 days
Pharmacokinetics in comparison with Kineret(Anakinra): Elimination half-life(T1/2)
To explore pharmacokinetics in comparison with subcutaneous administration of a positive comparator, Kineret(Anakinra)
Measured: 3 days
Pharmacokinetics in comparison with Kineret(Anakinra): Apparent Clearance(CL/F)
To explore pharmacokinetics in comparison with subcutaneous administration of a positive comparator, Kineret(Anakinra)
Measured: 3 days
Pharmacokinetics in comparison with Kineret(Anakinra): Apparent Volume of Distribution(Vz/F)
To explore pharmacokinetics in comparison with subcutaneous administration of a positive comparator, Kineret(Anakinra)
Measured: 3 days
Pharmacokinetics in comparison with Kineret(Anakinra): Mean Residence Time (MRT)
To explore pharmacokinetics in comparison with subcutaneous administration of a positive comparator, Kineret(Anakinra)
Measured: 3 days
Pharmacodynamics in comparison with Kineret(Anakinra): IL-6 inhibition assay
To explore pharmacodynamics in comparison with subcutaneous administration of a positive comparator, Kineret(Anakinra)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionFeb 2015
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyeong Ki Lee, Professor, Principal investigator, Clinical Trial Center, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175056
- Sponsor's protocol ID
- HL_C101
- Status last verified
- Oct 2015
- First submitted
- 17 Jun 2014
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Block Randomized, Placebo Controlled (Double-blind), Active Controlled(Open-label), Dose-escalation Study to Investigate the Tolerability, and Pharmacokinetics/Pharmacodynamics of HL2351 After a Single Subcutaneous Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02175056
- Acronym / sponsor ID
- HL_C101
- Conditions
- Healthy Volunteers
- Keywords
- First In Human, CAPS, SoJIA, AOSD, Bechet Disease, Rheumatoid arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Jun 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 study design of this trial is a Dose-Block Randomized, Placebo controlled (Double-blind), Active Controlled(Open-label), Dose-escalation.
Detailed description
- Extended in vivo half-life of HL2351 is also anticipated to provide improved therapeutic efficacy based on sustained maintenance of an effective concentration.
- A safety concern may be addressed by utilizing IL-1Ra that is being used after getting approval by the EMA and the US FDA and known to be relatively safe, and the Fc fusion technology that has been already applied to various therapeutic agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HL2351 | Experimental | Biological: HL23511, 2, 4, 8, 12 mg/kg (SC) / Single-Dose |
| Placebo | Placebo comparator | Biological: HL23511, 2, 4, 8, 12 mg/kg (SC) / Single-Dose |
| Kineret(Anakinra) | Active comparator | Biological: Kineret(Anakinra)100 mg (SC) / Single-Dose |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A healthy adult man aged between 20 and 45 years (inclusive) at screening
- Weight between 55 and 90 kg (inclusive) and the body mass index(BMI) between 18.0 and 27.0 (inclusive)
- Voluntary consent to participation in this study and signature on the IRB-approved informed consent form after being explained about characteristics of this clinical study, prior to any screening test
Key exclusion criteria (17 listed)
- Current or history of a clinically significant hepatic, renal, neurological, immunological, respiratory or endocrine disease or hematological or oncological disease, cardiovascular disease or psychiatric disease (mood disorder or compulsive disorder, etc.) (in case of a hepatic disease, a hepatitis virus-infected subject may be also included)
- Hypersensitivity to a drug (aspirin or antibiotics, etc.) or past history of clinically significant hypersensitivity
- In sitting vital signs measured after resting for 3 min or more, systolic blood pressure of <90mmHg or >150mmHg, or diastolic blood pressure of <60mmHg or >100 mmHg
- Past history of drug abuse or positive urine drug screening results
- Use of any prescription medicine or oriental medicine within 2 weeks or use of any over-the-counter(OTC) medication or vitamin preparation within 1 week prior to the scheduled first dose (however, a subject may be included if other conditions are satisfied, at the discretion of the investigator)
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 |
|---|---|---|
| HL2351Dose-escalation For 5 level dose groups A ~ E(each 1, 2, 4, 8, 12mg/kg), 10 subjects (8 for the study drug and 2 for placebo) are randomized to each dose group, and the study drug or placebo is subcutaneously administered for the relevant dose group. | Biological | HL2351, Placebo |
| Kineret(Anakinra)Active comparator(group F) is implemented in parallel with dose groups A~E in an open-label manner and 8 subjects subcutaneously administer Kineret® 100 mg. | Biological | Kineret(Anakinra) |
Primary outcome
Tolerability as measured by the occurrence of Adverse Events
Time frame: 29 days
Adverse Events after single subcutaneous dose of HL2351 : check Day -1, 1, 2, 3, 4, 5, 7, 11, 15, 22, 29
Tolerability as measured by Physical Examination, Vital Signs and Safety Laboratory Tests
Time frame: 29 days
Changes from baseline in physical examination, vital signs, ECG, clinical laboratory tests (routine hematology, routine chemistry, blood coagulation and urinalysis) after single subcutaneous dose of HL2351
Tolerability as measured by the occurrence of Local Toxicity
Time frame: 4 days
Local Toxicity after single subcutaneous dose of HL2351 : check Day 1, 2, 4
Tolerability as measured by Cytokine Laboratory Test
Time frame: 4 days
Cytokine Laboratory Test after single subcutaneous dose of HL2351 : check Day 1, 2, 4
Pharmacokinetics of HL2351: Maximum plasma concentration(Cmax)
Time frame: 29 days
To assess pharmacokinetics after single subcutaneous injection of HL2351
Pharmacokinetics of HL2351: Area under plasma drug concentration-time curve [AUC(0-last), AUCinf]
Time frame: 29 days
To assess pharmacokinetics after single subcutaneous injection of HL2351
Pharmacokinetics of HL2351: Time of maximum concentration(Tmax)
Time frame: 29 days
To assess pharmacokinetics after single subcutaneous injection of HL2351
Pharmacokinetics of HL2351: Elimination half-life(T1/2)
Time frame: 29 days
To assess pharmacokinetics after single subcutaneous injection of HL2351
Pharmacokinetics of HL2351: Apparent Clearance(CL/F)
Time frame: 29 days
To assess pharmacokinetics after single subcutaneous injection of HL2351
Pharmacokinetics of HL2351: Apparent Volume of Distribution(Vz/F)
Time frame: 29 days
To assess pharmacokinetics after single subcutaneous injection of HL2351
Pharmacokinetics of HL2351: Mean Residence Time (MRT)
Time frame: 29 days
To assess pharmacokinetics after single subcutaneous injection of HL2351
Pharmacodynamics of HL2351: IL-6 inhibition assay
Time frame: 7 days
To assess the pharmacodynamic dose-response relationship after single subcutaneous injection of HL2351 IL-6 inhibition assay: AUEClast, Emax
13 secondary outcomes
Immunogenicity of HL2351: Anti-drug Antibody
Time frame: Day 1, Day 29
Tolerability in comparison with Kineret(Anakinra): measured by the occurrence of Adverse Events
Time frame: 3 days
Tolerability in comparison with Kineret(Anakinra): measured by Physical Examination, Vital Signs and Safety Laboratory Tests
Time frame: 3 days
Tolerability in comparison with Kineret(Anakinra): measured by the occurrence of Local Toxicity
Time frame: 3 days
Tolerability in comparison with Kineret(Anakinra): measured by Cytokine Laboratory Test
Time frame: 3 days
Pharmacokinetics in comparison with Kineret(Anakinra): Maximum plasma concentration
Time frame: 3 days
Pharmacokinetics in comparison with Kineret(Anakinra): Area under plasma drug concentration-time curve [AUC(0-last), AUCinf]
Time frame: 3 days
Pharmacokinetics in comparison with Kineret(Anakinra): Time of maximum concentration(Tmax)
Time frame: 3 days
Pharmacokinetics in comparison with Kineret(Anakinra): Elimination half-life(T1/2)
Time frame: 3 days
Pharmacokinetics in comparison with Kineret(Anakinra): Apparent Clearance(CL/F)
Time frame: 3 days
Pharmacokinetics in comparison with Kineret(Anakinra): Apparent Volume of Distribution(Vz/F)
Time frame: 3 days
Pharmacokinetics in comparison with Kineret(Anakinra): Mean Residence Time (MRT)
Time frame: 3 days
Pharmacodynamics in comparison with Kineret(Anakinra): IL-6 inhibition assay
Time frame: 1 day
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 6 Oct 2015.
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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.
Hyeong Ki Lee, Professor principal investigator
Clinical Trial Center, Seoul National University 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 HL2351 and Kineret(Anakinra) in people with Healthy Volunteers, run by Handok Inc. 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 17 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 6 Oct 2015. 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. Some participants in this study may receive a placebo. 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?
Tolerability as measured by the occurrence of Adverse Events (time frame: 29 days). The study lists 12 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 6 Oct 2015.