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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT02460393
• Date of registration: 18/01/2015
• Prospective Registration: Yes
• Primary sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
• Public title: A Trial With Humanized TNFa Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy Subjects
• Scientific title: A Randomized, Double Blind, Placebo Controlled Trial With Humanized TNFa Monoclonal Antibody Injection by Single Dose and Dose Escalation to Explore the Tolerance, Safety and Pharmacokinetic Characteristics in Healthy Subjects
• Date of first enrolment: May 2015
• Target sample size: 72
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02460393
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

China

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Humanized TNFa monoclonal antibody

Other: placebo

Primary Outcome(s)

Tmax [Time Frame: 28 days]

Cmin [Time Frame: 28 days]

AUC [Time Frame: 28 days]

Cmax [Time Frame: 28 days]

Secondary Outcome(s)

Serum creatinine and AST and ALT [Time Frame: 28 days]

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

Secondary ID(s)

sss07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors