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

Rheumatic Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525147
• Other study ID #: YHB1411-2-101
• Status: Completed
• Phase: Phase 1
• First received: January 26, 2012
• Last updated: July 8, 2014
• Start date: December 2011
• Est. completion date: November 2013

Study information

• Verified date: July 2014
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical 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

Description:

First in human Study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rheumatic Arthritis
• Rheumatic Fever

Intervention

Biological:
• YHB1411-2: Level 2
IV infusion
• YHB1411-2: Level 3
IV infusion
• YHB1411-2: Level 4
IV infusion
• YHB1411-2: Level 5
IV infusion
• Placebo
IV infusion
• YHB1411-2: level 1
IV infusion

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Irwon-dong, Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No