Healthy SubjectsPhase 1NCT02206867
Pharmacokinetics and Safety Study of LBAL in Healthy Subjects
A Phase 1 study testing LBAL and Humira in people with Healthy Subjects, run by LG Life Sciences.
Trial summary
To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®. 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 Subjects
- What is being tested?
- LBAL and Humira
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Aug 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
- 20-45 years old healthy males
- Body mass index 19.0 ~ 28.0 kg/m2
Who cannot join
- Diagnosis of current or latent tuberculosis (TB); history of severe active chronic or local infection including TB
- Severe infection (e.g. sepsis) requiring admission or antibiotics treatment within four weeks prior to administration
- Clinically relevant previous or concomitant disease including hepatic, renal, neurological, respiratory, gastrointestinal, endocrine, hematologic, oncologic, cardiovascular, urinary, musculoskeletal or psychiatric, autoimmune disease/disorders
- Chronic or relevant acute infections. A negative result for human immunodeficiency virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for participation (i.e. HIV Ab, HBsAg, HBcAb, HCV Ab)
- Fever greater than 38.3℃ within a week prior to administration of study drug
- Previous or current drug abuse
About this study
Official title: A Randomized, Double-Blind, Parallel-Group Clinical Study to Compare Pharmacokinetics, Safety and Tolerability of LBAL 40 mg With Humira® 40 mg After a Single Subcutaneous Administration in Healthy Male Volunteers
To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.
- Conditions
- Healthy Subjects
- Being tested
- LBAL, Humira
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBALBiological
Also called Adalimumab
Anti-inflammatory agents
HumiraBiological
Also called Adalimumab
Anti-inflammatory agents
| Study group | Role | What they receive |
|---|---|---|
| LBAL | Experimental | Developed by LG Life Sciences Receives: Biological: LBAL |
| Humira® | Active comparator | Abbvie Receives: Biological: Humira |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity
Measured: 0 to 65 days
Maximum measured concentration of the analyte in serum
Measured: 0 to 65 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 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 SubjectsStudies 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, M.D., Ph.D., M.B.A, Principal investigator, Dep. of Clnical Pharmacology, Seoul National University College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206867
- Sponsor's protocol ID
- LG-ALCL001
- Status last verified
- Jun 2015
- First submitted
- 30 Jul 2014
- Last updated
- 15 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group Clinical Study to Compare Pharmacokinetics, Safety and Tolerability of LBAL 40 mg With Humira® 40 mg After a Single Subcutaneous Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02206867
- Acronym / sponsor ID
- LG-ALCL001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 1 Aug 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.
To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBAL | Experimental | Biological: LBALDeveloped by LG Life Sciences |
| Humira® | Active comparator | Biological: HumiraAbbvie |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 20-45 years old healthy males
- Body mass index 19.0 ~ 28.0 kg/m2
Key exclusion criteria (6 listed)
- Diagnosis of current or latent tuberculosis (TB); history of severe active chronic or local infection including TB
- Severe infection (e.g. sepsis) requiring admission or antibiotics treatment within four weeks prior to administration
- Clinically relevant previous or concomitant disease including hepatic, renal, neurological, respiratory, gastrointestinal, endocrine, hematologic, oncologic, cardiovascular, urinary, musculoskeletal or psychiatric, autoimmune disease/disorders
- Chronic or relevant acute infections. A negative result for human immunodeficiency virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for participation (i.e. HIV Ab, HBsAg, HBcAb, HCV Ab)
- Fever greater than 38.3℃ within a week prior to administration of study drug
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 |
|---|---|---|
| LBALAlso: AdalimumabAnti-inflammatory agents | Biological | LBAL |
| HumiraAlso: AdalimumabAnti-inflammatory agents | Biological | Humira® |
Primary outcome
Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity
Time frame: 0 to 65 days
Maximum measured concentration of the analyte in serum
Time frame: 0 to 65 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 15 Jun 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.
Kyung-Sang Yu, M.D., Ph.D., M.B.A principal investigator
Dep. of Clnical Pharmacology, Seoul National University College of Medicine and Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LBAL and Humira in people with Healthy Subjects, run by LG Life Sciences.
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 2 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 15 Jun 2015. 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?
Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (time frame: 0 to 65 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 15 Jun 2015.