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Rheumatic ArthritisPhase 1NCT01525147

Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of YHB1411-2 in Healthy Male Volunteers

A Phase 1 study testing YHB1411-2: Level 2, YHB1411-2: Level 3 and YHB1411-2: Level 4 in people with Rheumatic Arthritis, run by Yuhan Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A block-randomized, double-blind, placebo-controlled, single-dose escalating, phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of YHB1411-2 in healthy male volunteers 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
Rheumatic Arthritis
What is being tested?
YHB1411-2: Level 2, YHB1411-2: Level 3 and YHB1411-2: Level 4
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
1 siteSouth Korea
Study dates
Dec 2011to Nov 2013
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

  • Healthy male volunteers of aged between 20 to 45 years old at the time of screening
  • Volunteers weighing over 50 kg with body mass index between 18.0 ~ 28.0 kg/m2
  • Volunteers who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug

Who cannot join

  • Have history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood•tumor, cardiovascular, urinary system, and mental disorder
  • Presence of current tuberculosis or latent tuberculosis or have history of tuberculosis (confirmed by chest X-ray test or tuberculin skin test)
  • Have active infection such as chronic or topical infection
  • Have history of hospitalization or have received antibiotics due to serious infection within 1 month prior to the first administration
  • Have know hypersensitivity to biologicals
  • Have AST(SGOT) or/and ALT(SGPT) > 1.5 times of normal upper limit at the time of screening
Show all 14Show fewer
  • Shown positive results in any of HBsAg, HCV Ab, HIV Ab tests
  • Have history of drug abuse or shown positive reaction of drug abuse in urine test at the time of screening
  • Received any biological drugs including monoclonal antibody products or protein drugs within the last 6 months prior to the first administration
  • Participated in any other clinical trials within 2 months prior to the first administration of Investigational Product
  • Have donated whole blood within 2 months prior to the first administration of Investigational Product, or donated blood components or received transfusion within 1 month prior to the first administration of Investigational Product
  • Subject who drink continuously (over 21 units/week, 1 unit = 10 g of pure alcohol) or who cannot quit drinking while hospitalized
  • Smoker (Subject can be enrolled if he/she had quit smoking within 3 months before the first administration of Investigational Product (Day 1))
  • Subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons including their abnormal test results (clinical laboratory test, chest X-ray test, 12-lead ECG)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, Irwon-dong, Gangnam-gu, 130-710

Other trials in South Korea

About this study

Official title: A Block-randomized, Double-blind, Placebo-controlled, Single-dose Escalating, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of YHB1411-2 in Healthy Male Volunteers

A block-randomized, double-blind, placebo-controlled, single-dose escalating, phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of YHB1411-2 in healthy male volunteers

Read the detailed description

First in human Study

Being tested
YHB1411-2: Level 2, YHB1411-2: Level 3, YHB1411-2: Level 4, YHB1411-2: Level 5, Placebo
Medical subject headings
Rheumatic Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YHB1411-2: Level 2Biological

    Also called Undecided

    IV infusion

  • YHB1411-2: Level 3Biological

    Also called Undecided

    IV infusion

  • YHB1411-2: Level 4Biological

    IV infusion

  • YHB1411-2: Level 5Biological

    Also called Undecided

    IV infusion

  • PlaceboBiological

    IV infusion

  • YHB1411-2: level 1Biological

    Also called Undecided

    IV infusion

Study groups in NCT01525147
Study groupRoleWhat they receive
YHB1411-2: Level 2ExperimentalThe ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.
Receives: Biological: YHB1411-2: Level 2; Biological: Placebo
YHB1411-2: Level 3ExperimentalThe ratio of Test Drug(YHB1411-2) to Placebo is 13 :2.
Receives: Biological: YHB1411-2: Level 3; Biological: Placebo
YHB1411-2: Level 4ExperimentalThe ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.
Receives: Biological: YHB1411-2: Level 4; Biological: Placebo
YHB1411-2: Level 5ExperimentalThe ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.
Receives: Biological: YHB1411-2: Level 5; Biological: Placebo
YHB1411-2: Level 1ExperimentalAll investigational products are YHB1411-2(This level is pilot study).
Receives: Biological: YHB1411-2: level 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Evaluation

    Adverse Events, Physical examination, ECG, Vital sign, Clinical Laboratory Tests results, Chest X-ray

    Measured: Participants will be followed for the duration of hospital stay(an expected average of 1 week) and out-patient visit for 8 weeks → Specified timepoints in the protocol.

Secondary outcomes (2)

  1. Pharmacokinetic Evaluation

    Measured: PK sampling : participants will be followed for the duration of hospital stay(an expected average of 1 week) and out-patient visit for 8 weeks → Specified timepoints in the protocol.

  2. Immunogenicity Evaluation

    1. HAHA (Human anti human antibodies) measurement
    2. Neutralizing Antibody measurement: only if antibody formation has verified

    Measured: HAHA measurement(blood sampling): pre-dose and out-patient visit for 8 weeks → Specified timepoints in the protocol.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionJun 2013
  4. Study completionNov 2013

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01525147
Sponsor's protocol ID
YHB1411-2-101
Status last verified
Jul 2014
First submitted
26 Jan 2012
Last updated
10 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YHB1411-2: Level 2, YHB1411-2: Level 3 and YHB1411-2: Level 4 in people with Rheumatic Arthritis, run by Yuhan Corporation 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 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 10 Jul 2014. 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?

Safety Evaluation (time frame: Participants will be followed for the duration of hospital stay(an expected average of 1 week) and out-patient visit for 8 weeks → Specified timepoints in the protocol.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01525147.

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 10 Jul 2014.

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