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Trial record 5 of 560 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.

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Humanized TNFα monoclonal antibody Other: placebo Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: placebo
Subcutaneous injection of different doses for healthy people

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.
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




Primary Outcome Measures :
  1. AUC [ Time Frame: 28 days ]
    AUC

  2. Cmax [ Time Frame: 28 days ]
    Cmax

  3. Cmin [ Time Frame: 28 days ]
    Cmin

  4. Tmax [ Time Frame: 28 days ]
    Tmax


Secondary Outcome Measures :
  1. Serum creatinine and AST and ALT [ Time Frame: 28 days ]
    Serum creatinine and AST and ALT

  2. or any other adverse events [ Time Frame: 28 days ]
    or any other adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460393


Locations
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China, Beijing
Peking University People's Hospital
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Shenyang Sunshine Pharmaceutical Co., LTD.

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Responsible Party: Shenyang Sunshine Pharmaceutical Co., LTD.
ClinicalTrials.gov Identifier: NCT02460393     History of Changes
Other Study ID Numbers: sss07
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

Keywords provided by Shenyang Sunshine Pharmaceutical Co., LTD.:
tolerance
safety and pharmacokinetic characteristics

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents