Beijing SHIJITAN Hospital
Beijing, Beijing Municipality, 100038, China
NCT Number: NCT03917628
Investigate the pharmacokinetics, safety and tolerability of SCT630 and to establish pharmacokinetic similarity of SCT630 to adalimumab.
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Beijing, Beijing Municipality, 100038, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SCT630 single s.c. injection
adalimumab-EU source single s.c. injection
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 through Day 71
λz of SCT630 and EU-licensed Humira
Time frame: Day 1 through Day 71
Clearance rate of the SCT630 and EU-licensed Humira
Time frame: Day 1 through Day 71
Apparent volume of distribution (Vd) of the SCT630 and EU-licensed Humira
Time frame: Day 1 through Day 71
Time frame: Day 1 through Day 71
Comparision of the positive rate of ADA and NAb between the SCT630 and EU-licensed Humira
Sinocelltech Ltd.
Industry
Pharmacokinetics and Safety of SCT630 in Healthy Subjects: a Randomized, Double-blind, Single Dose Clinical Phase I Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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