Healthy
Conditions
Brief summary
Investigate the pharmacokinetics, safety and tolerability of SCT630 and to establish pharmacokinetic similarity of SCT630 to adalimumab.
Interventions
DRUGSCT630
SCT630 single s.c. injection
adalimumab-EU source single s.c. injection
Sponsors
Sinocelltech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male subjects aged 18 to 45 years 2. Body mass index (BMI) between 19 and 26 kg/m2 3. Normal or clinically acceptable physical examination, clinical laboratory values, ECG, chest X-ray and vital signs at screening and baseline. 4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Exclusion criteria
1. History or evidence of a clinically significant disorder, condition, or disease that would have posed a risk to subject safety or would have interfered with the study evaluation, procedures, or study completion in the opinion of the investigator. 2. Evidence of any bacterial, viral, parasitic, systemic fungal infections, or infections due to other opportunistic pathogens within the 30 days prior to investigational product administration. 3. History of tuberculosis,positive test for Interferon-gamma-release assay,or suffering from active tuberculosis or latent tuberculosis infection. 4. History of malignancy of any type, other than surgically excised nonmelanomatous skin cancers, within 5 years prior to investigational product administration. 5. Positive test for HIV antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies at screening. 6. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients). 7. Quantification of Hepatitis B virus DNA is greater than the upper limit of normal value. 8. Received biologics or live vaccines ≤3 months prior to investigational product administration. 9. Intake of an investigational drug in another trial within three months prior to investigational product administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-tz | at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing. | Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of SCT630 and EU-licensed Humira |
| Cmax | at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing. | Maximum Concentration (Cmax) of SCT630 and EU-licensed Humira |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2 | at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing. | Elimination Phase Half-life of SCT630 and EU-licensed Humira |
| λz | Day 1 through Day 71 | λz of SCT630 and EU-licensed Humira |
| CL | Day 1 through Day 71 | Clearance rate of the SCT630 and EU-licensed Humira |
| AUC 0-∞ | at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing. | Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of SCT630 and EU-licensed Humira |
| Number (Proportion) of Subjects With Drug Related Adverse Events | Day 1 through Day 71 | — |
| Positive rate of ADA and NAb | Day 1 through Day 71 | Comparision of the positive rate of ADA and NAb between the SCT630 and EU-licensed Humira |
| Vd | Day 1 through Day 71 | Apparent volume of distribution (Vd) of the SCT630 and EU-licensed Humira |
| Tmax | at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing. | Time to the Maximum Concentration of SCT630 and EU-licensed Humira |
Countries
China
Outcome results
None listed