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

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

Study Overview

• Status: Completed
• Conditions: Rheumatic Arthritis
• Intervention / Treatment: Biological: YHB1411-2: Level 2; Biological: Placebo; Biological: YHB1411-2: Level 3; Biological: YHB1411-2: Level 4; Biological: YHB1411-2: Level 5; Biological: YHB1411-2: level 1

Detailed Description

First in human Study

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Irwon-dong, Gangnam-gu
    • Seoul, Irwon-dong, Gangnam-gu, Korea, Republic of, 130-710
      • Samsung medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YHB1411-2: Level 2; The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.	Biological: YHB1411-2: Level 2; IV infusion; Other Names: Undecided; Biological: Placebo; IV infusion
Experimental: YHB1411-2: Level 3; The ratio of Test Drug(YHB1411-2) to Placebo is 13 :2.	Biological: Placebo; IV infusion; Biological: YHB1411-2: Level 3; IV infusion; Other Names: Undecided
Experimental: YHB1411-2: Level 4; The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.	Biological: Placebo; IV infusion; Biological: YHB1411-2: Level 4; IV infusion
Experimental: YHB1411-2: Level 5; The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.	Biological: Placebo; IV infusion; Biological: YHB1411-2: Level 5; IV infusion; Other Names: Undecided
Experimental: YHB1411-2: Level 1; All investigational products are YHB1411-2(This level is pilot study).	Biological: YHB1411-2: level 1; IV infusion; Other Names: Undecided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Evaluation	Adverse Events, Physical examination, ECG, Vital sign, Clinical Laboratory Tests results, Chest X-ray	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (Human anti human antibodies) measurement; Neutralizing Antibody measurement: only if antibody formation has verified	HAHA measurement(blood sampling): pre-dose and out-patient visit for 8 weeks → Specified timepoints in the protocol.

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Woo-Seung Huh, MD,PhD., Samsung medical center

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: January 26, 2012
• First Submitted That Met QC Criteria: January 30, 2012
• First Posted (Estimate): February 2, 2012

Study Record Updates

• Last Update Posted (Estimate): July 10, 2014
• Last Update Submitted That Met QC Criteria: July 8, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Rheumatic Fever
• Other Study ID Numbers: YHB1411-2-101