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

Phase 1

Completed

• Conditions: Rheumatic Arthritis
• Interventions: Biological: Placebo

• Registration Number: NCT01525147
• Lead Sponsor: Yuhan Corporation

Brief 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

Detailed Description

First in human Study

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-02
• Primary Completion: 2013-06
• Study Completion: 2013-11
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

Inclusion Criteria

1. Healthy male volunteers of aged between 20 to 45 years old at the time of screening
2. Volunteers weighing over 50 kg with body mass index between 18.0 ~ 28.0 kg/m2
3. 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

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Exclusion Criteria

1. 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
2. Presence of current tuberculosis or latent tuberculosis or have history of tuberculosis (confirmed by chest X-ray test or tuberculin skin test)
3. Have active infection such as chronic or topical infection
4. Have history of hospitalization or have received antibiotics due to serious infection within 1 month prior to the first administration
5. Have know hypersensitivity to biologicals
6. Have AST(SGOT) or/and ALT(SGPT) > 1.5 times of normal upper limit at the time of screening
7. Shown positive results in any of HBsAg, HCV Ab, HIV Ab tests
8. Have history of drug abuse or shown positive reaction of drug abuse in urine test at the time of screening
9. Received any biological drugs including monoclonal antibody products or protein drugs within the last 6 months prior to the first administration
10. Participated in any other clinical trials within 2 months prior to the first administration of Investigational Product
11. 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
12. Subject who drink continuously (over 21 units/week, 1 unit = 10 g of pure alcohol) or who cannot quit drinking while hospitalized
13. Smoker (Subject can be enrolled if he/she had quit smoking within 3 months before the first administration of Investigational Product (Day 1))
14. 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YHB1411-2: Level 3	Placebo	The ratio of Test Drug(YHB1411-2) to Placebo is 13 :2.
YHB1411-2: Level 5	Placebo	The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.
YHB1411-2: Level 4	Placebo	The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.
YHB1411-2: Level 2	Placebo	The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.

Primary Outcome Measures

Name	Time	Method
Safety Evaluation	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.	Adverse Events, Physical examination, ECG, Vital sign, Clinical Laboratory Tests results, Chest X-ray

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Evaluation	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.
Immunogenicity Evaluation	HAHA measurement(blood sampling): pre-dose and out-patient visit for 8 weeks → Specified timepoints in the protocol.	1. HAHA (Human anti human antibodies) measurement; 2. Neutralizing Antibody measurement: only if antibody formation has verified

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Irwon-dong, Gangnam-gu, Korea, Republic of