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Trial record 5 of 561 for:    Cachectin OR Tumor Necrosis Factor-alpha

A Trial With Humanized TNFα Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02460393
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Shenyang Sunshine Pharmaceutical Co., LTD.

Tracking Information
First Submitted Date  ICMJE January 18, 2015
First Posted Date  ICMJE June 2, 2015
Last Update Posted Date December 27, 2017
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2017)
  • AUC [ Time Frame: 28 days ]
    AUC
  • Cmax [ Time Frame: 28 days ]
    Cmax
  • Cmin [ Time Frame: 28 days ]
    Cmin
  • Tmax [ Time Frame: 28 days ]
    Tmax
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2015)
  • AUC [ Time Frame: 28 days ]
  • Cmax [ Time Frame: 28 days ]
  • Cmin [ Time Frame: 28 days ]
  • Tmax [ Time Frame: 28 days ]
Change History Complete list of historical versions of study NCT02460393 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2017)
  • Serum creatinine and AST and ALT [ Time Frame: 28 days ]
    Serum creatinine and AST and ALT
  • or any other adverse events [ Time Frame: 28 days ]
    or any other adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2015)
  • Serum creatinine and AST and ALT [ Time Frame: 28 days ]
  • or any other adverse events [ Time Frame: 28 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial With Humanized TNFα Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy Subjects
Official Title  ICMJE A Randomized, Double Blind, Placebo Controlled Trial With Humanized TNFα Monoclonal Antibody Injection by Single Dose and Dose Escalation to Explore the Tolerance, Safety and Pharmacokinetic Characteristics in Healthy Subjects
Brief Summary This study is a randomized, double-blind and placebo-controlled trial with healthy subjects. There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12 people. A single subcutaneous injection will be administrated starting from the low dose group (in accordance with 5mg, 15mg, 30mg, 50mg, 75mg, 100mg administered subcutaneously). Pharmacokinetics and pharmacodynamics data will be collected; drug metabolism and pharmacokinetics characteristics will be analyzed. Drug safety and tolerance for subjects will be evaluated.
Detailed Description

This study is a randomized, double-blind and placebo-controlled trial with healthy subjects. There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12 people. A single subcutaneous injection will be administrated starting from the low dose group (in accordance with 5mg, 15mg, 30mg, 50mg, 75mg, 100mg administered subcutaneously). Pharmacokinetics and pharmacodynamics data will be collected; drug metabolism and pharmacokinetics characteristics will be analyzed. Drug safety and tolerance for subjects will be evaluated.

The study observed blood concentrations of the experimental drug at different time points after and before administration, TNFα before and after treatment at different time points will be observed as well.

C-T curve will be drawn with blood drug concentration (c) and time (T) in the trial. At the same time, the investigators will draw the average plasma concentration curve. Compartmental and non compartmental model will be used to analyze the pharmacokinetic parameters of subjects. It will be judged with linear or nonlinear elimination by the correlation analysis of AUC, Cmax of different doses. In the meantime, adverse events, vital signs, physical examination, laboratory examination and ECG will be evaluated.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Humanized TNFα monoclonal antibody

    Subcutaneous injection of different doses for healthy people

    Subcutaneous injection of different doses in healthy people

    Other Name: TNFα monoclonal antibody
  • Other: placebo
    Subcutaneous injection of different doses for healthy people
Study Arms  ICMJE
  • Placebo Comparator: Placebo group
    The arm is as a control group to study the tolerance, safety and pharmacokinetic characteristics of Subcutaneous injection of different doses of humanized TNFα monoclonal antibody.
    Intervention: Other: placebo
  • Experimental: experimental group
    The arm is as an experimental group to study the tolerance, safety and pharmacokinetic characteristics of Subcutaneous injection of different doses of humanized TNFα monoclonal antibody.
    Intervention: Drug: Humanized TNFα monoclonal antibody
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2015)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. healthy adult volunteers who are voluntary to participate in clinical trials, and signed the informed consent
  2. aged 18-45 years, the same batch of subjects age difference is less than or equal to 10 years of age
  3. subjects with qualified physical examination within 7 days before the trial, body mass index (BMI) from19 to 24 ,and the same batch of subjects are with the similar weight
  4. the basic indicators of heart, liver, kidney and blood examination are in the normal range.

Exclusion Criteria:

  1. subjects are during the acute or chronic infection period, or have a previous history of active tuberculosis
  2. subjects are with the history of diseases of the central nervous system, cardiovascular system, kidney, liver (specific indexes of liver function), digestive system ,respiratory system or metabolic system or suffered from other significant disease
  3. subjects as allergic constitution after inquiry, suspected or confirmed or have a history of drug, food allergy , or subjects with a clear history of allergies and / or allergic to the humanized TNF alpha monoclonal antibody or the ingredient of humanized TNF alpha monoclonal antibody , or serum immunoglobulin E (IgE) examination was abnormal
  4. subjects are included in other clinical trials of other drugs 3 months before being enrolled in this clinical trial, or candidates used drugs known to have damage to the main organs within 3 months before this trial;
  5. candidates with blood donation history 3 months before being enrolled
  6. Prescription and non prescription drugs were administrated Within 2 weeks before inclusion
  7. ALT or AST > 1.5N (the upper limit of normal), Cr>N (the upper limit of normal);
  8. leukocyte absolute value less than 3.50 × 109/L or > 9.50× 109/L, neutrophil absolute value less than 1.8× 109/L, platelet counts less than 100 × 109/L, hemoglobin is less than 100g/L
  9. hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome (Anti-HIV) antibody and anti Treponema pallidum antibody (TP-Ab) are positive subjects
  10. candidates with positive tuberculin skin test with 5 unit dose tuberculin , the size of 48-72 hour scleroma greater than 5 mm
  11. subjects with positive anti nuclear antibodies (ANA, ds-DNA, ENA)
  12. subjects with positive resistantance antibody
  13. subjects had a history of mental illness
  14. subjects who are pregnant, lactating women or a planning pregnant within 3 months
  15. subjects with the history of orthostatic hypotension
  16. with drug or drug abuse history after inquiry
  17. daily smoking more than 5 cigarettes or the same amount of tobacco after inquiry
  18. subjects drink more than 28 units of alcohol after inquiry, or alcohol breath test are positive within 24 hours before the acceptance of the tested drugs
  19. There is a family history of cancer
  20. Significantly abnormal values in clinical appeared during the screening
  21. subjects cannot understand, exchangeand cooperate enough, and cannot guarantee the researchers according to the scheme
  22. researchers don't think it is right to participate in the research with other reasons.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02460393
Other Study ID Numbers  ICMJE sss07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shenyang Sunshine Pharmaceutical Co., LTD.
Study Sponsor  ICMJE Shenyang Sunshine Pharmaceutical Co., LTD.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shenyang Sunshine Pharmaceutical Co., LTD.
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP