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

NCT02460393 | Completed Phase 1

• 1 other identifier: sss07
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

tolerance; safety and pharmacokinetic characteristics

Outcome Measures

Primary Outcomes (4)

• AUC

  AUC

  28 days

• Cmax

  Cmax

  28 days

• Cmin

  Cmin

  28 days

• Tmax

  Tmax

  28 days

Secondary Outcomes (2)

• Serum creatinine and AST and ALT

  28 days

• or any other adverse events

  28 days

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

experimental group

EXPERIMENTAL

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

Interventions

Humanized TNFα monoclonal antibody DRUG

Subcutaneous injection of different doses for healthy people Subcutaneous injection of different doses in healthy people

Also known as: TNFα monoclonal antibody

experimental group

placebo OTHER

Subcutaneous injection of different doses for healthy people

Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy adult volunteers who are voluntary to participate in clinical trials, and signed the informed consent
• aged 18-45 years, the same batch of subjects age difference is less than or equal to 10 years of age
• 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
• the basic indicators of heart, liver, kidney and blood examination are in the normal range.

You may not qualify if:

• subjects are during the acute or chronic infection period, or have a previous history of active tuberculosis
• 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
• 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
• 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;
• candidates with blood donation history 3 months before being enrolled
• ALT or AST \> 1.5N (the upper limit of normal), Cr\>N (the upper limit of normal);
• 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
• 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
• candidates with positive tuberculin skin test with 5 unit dose tuberculin , the size of 48-72 hour scleroma greater than 5 mm
• subjects with positive anti nuclear antibodies (ANA, ds-DNA, ENA)
• subjects with positive resistantance antibody
• subjects had a history of mental illness
• subjects who are pregnant, lactating women or a planning pregnant within 3 months
• subjects with the history of orthostatic hypotension
• with drug or drug abuse history after inquiry

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2015
• First Posted: June 2, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 27, 2017

Record last verified: 2017-12

Locations

CN (1)