A Phase 1, Randomized, Double-Blind and Paralle, Controlled Single-dose Clinical Trial of Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of QX003S and Tocilizumab in Chinese Health Male Subjects

• Register: ChiCTR
• Last refreshed on: 18 March 2019
• Main ID: ChiCTR1900021808
• Date of registration: 2019-03-11
• Prospective Registration: No
• Primary sponsor: JiangSu Qyuns Therapeutics Co., Ltd
• Public title: A Phase 1, Randomized, Double-Blind and Paralle, Controlled Single-dose Clinical Trial of Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of QX003S and Tocilizumab in Chinese Health Male Subjects
• Scientific title: A Phase 1, Randomized, Double-Blind and Paralle, Controlled Single-dose Clinical Trial of Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of QX003S and Tocilizumab in Chinese Health Male Subjects
• Date of first enrolment: 2019-03-08
• Target sample size: 1:43;2:43;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=36723
• Study type: Interventional study
• Study design: Parallel
• Phase: 1

Countries of recruitment

China

Contacts

• Name: Ding Yanhua
• Affiliation: the First Hospital of Jilin University

• Name: wangying
• Affiliation: Jiangsu Qyuns Therapeutics Co.,Ltd.

Key inclusion & exclusion criteria

Inclusion criteria: 1. Ability to fully understand the purpose, characteristic, method and the possible adverse effects of the trial, and voluntarily signed Informed Consent obtained before any trial-related procedures are performed. Ability to comply with the requirements of this trial protocol;
2. Subjects (including partners) without family planning are willing to adopt effective contraceptive measures within the next six months (see Appendix 4 for specific contraceptive measures);
3. Male adult between 18 and 50 years of age inclusive, at the time of signing the informed consent;
4. Male subjects weighed more than 50 kg and less than 85 kg;Body mass index (BMI) within the range 18–28 kg/m2 (inclusive) BMI(kg/m2) = body weight(kg)/height(m)2;
5. The vital signs, physical examinations, laboratory examinations and electrocardiograms, chest radiographs and abdominal color Doppler ultrasound were normal or abnormal without clinical significance.
Exclusion criteria: 1. Allergic history to test drugs, allergic constitution (allergic to multiple drugs and food);
2. Major operations should be performed within 30 days before signing ICF;
3. Drug abusers who had a history of drug abuse in the past five years or used drugs three months before the test, or those who had positive urine drug abuse screening;
4. Within 3 months before screening, blood loss or blood donation (including component donation) were greater than 400 mL; within 1 month before screening, blood loss or blood donation (including component donation) were greater than 200 mL;
5. Those who received blood transfusion within 8 weeks before screening;
6. Those who drank more than 14 units of alcohol per week in the first six months (1 unit of alcohol = 285 mL beer or 40% spirits or 100 mL wine with 25 mL of alcohol) or who took alcoholic products two days before administration were screened;
7. Patients with immune system diseases and medical history;
8. Have a history of serious systemic diseases and related diseases (including active or occult tuberculosis, suspected tuberculosis patients, psychiatric or psychiatric history, malignant tumors and their history, herpes zoster and its history, epilepsy and its history);
9. The disease history of cardiovascular disease, liver disease, kidney disease, digestive tract disease, mental disease, nerve disease, hematology disease, metabolic disorder and so on in the previous year were screened, and it was judged by the researchers to be abnormal with clinical significance;
10. Intrusive systemic fungal infections or other opportunistic infections occurred within 2 months before screening.
11. Systemic or local infections, such as the risk of sepsis or known active symptoms, occur within 2 months before screening;
12. Severe infections were hospitalized and/or required intravenous antibiotics within 2 months before screening.
13. Four or more upper respiratory tract infections occurred within 6 months before screening;
14. Screening for active systemic infections (except colds) or any other infections that recur regularly in the first two weeks;
15. Unable or unwilling to undergo repeated venipuncture (for example, due to poor tolerance or lack of venous access);
16. Those who have participated in clinical trials of any drug or medical device within three months prior to the use of the drug;
17. Those who receive live (attenuated) vaccines within 12 weeks before screening or who plan to receive live (attenuated) vaccines during screening and research visits;
18. Drugs targeting TNF and interleukin cytokines were used in the first year of screening;
19. Those who plan to receive any biological drug or monoclonal antibody drug within three months or nine months after the administration of the experimental drug;
20. Employees or related personnel of researchers, research centres, bidders and contractual research organizations;
21. HBsAg positive or HBsAg negative, HBV core antibody positive and HBV DNA quantitative > 0 (IU/ml); HCV antibody, syphilis antibody, HIV antibody positive;
22. During the screening or baseline period, CRP level was 1.5 times higher than the upper limit of the normal range.
23.Researchers think that it is not suitable for inclusion.

Age minimum: 18
Age maximum: 50
Gender: Male

Health Condition(s) or Problem(s) studied

Active rheumatoid arthritis

Intervention(s)

1:8 mg/kg QX003S ;2:Tocilizumab, 8 mg/kg;

Primary Outcome(s)

Pharmacokinetic indices;

Secondary Outcome(s)

Immunogenicity index;

Source(s) of Monetary Support

At sponsor's own expense

Ethics review

Status: Approved
Approval date: 26/08/2018
Contact:

Zhao Liyuan