Pharmacokinetics and Safety in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Investigate the pharmacokinetics, safety and tolerability of SCT630 and to establish pharmacokinetic similarity of SCT630 to adalimumab.

Official Title
-----------------
Pharmacokinetics and Safety of SCT630 in Healthy Subjects: a Randomized, Double-blind, Single Dose Clinical Phase I Study.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: SCT630
* Drug: adalimumab-EU source


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects aged 18 to 45 years Body mass index (BMI) between 19 and 26 kg/m2 Normal or clinically acceptable physical examination, clinical laboratory values, ECG, chest X-ray and vital signs at screening and baseline. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation. Exclusion Criteria: 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. 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. History of tuberculosis,positive test for Interferon-gamma-release assay,or suffering from active tuberculosis or latent tuberculosis infection. History of malignancy of any type, other than surgically excised nonmelanomatous skin cancers, within 5 years prior to investigational product administration. Positive test for HIV antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies at screening. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients). Quantification of Hepatitis B virus DNA is greater than the upper limit of normal value. Received biologics or live vaccines ≤3 months prior to investigational product administration. Intake of an investigational drug in another trial within three months prior to investigational product administration.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCT630<br>Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing SCT630 | Drug: SCT630<br>* SCT630 single s.c. injection<br>|
| Active Comparator: adalimumab-EU source<br>Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-EU source | Drug: adalimumab-EU source<br>* adalimumab-EU source single s.c. injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-tz | Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of SCT630 and EU-licensed Humira | 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. | 
| Cmax | Maximum Concentration (Cmax) of SCT630 and EU-licensed Humira | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC 0-∞ | Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of SCT630 and EU-licensed Humira | 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. | 
| Tmax | Time to the Maximum Concentration of SCT630 and EU-licensed Humira | 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. | 
| t1/2 | Elimination Phase Half-life of SCT630 and EU-licensed Humira | 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. | 
| λz | λz of SCT630 and EU-licensed Humira | Day 1 through Day 71 | 
| CL | Clearance rate of the SCT630 and EU-licensed Humira | Day 1 through Day 71 | 
| Vd | Apparent volume of distribution (Vd) of the SCT630 and EU-licensed Humira | Day 1 through Day 71 | 
| Number (Proportion) of Subjects With Drug Related Adverse Events |  | Day 1 through Day 71 | 
| Positive rate of ADA and NAb | Comparision of the positive rate of ADA and NAb between the SCT630 and EU-licensed Humira | Day 1 through Day 71 |