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OpenTrials
Completed

NCT Number: NCT03917628

Pharmacokinetics and Safety in Healthy Volunteers

Investigate the pharmacokinetics, safety and tolerability of SCT630 and to establish pharmacokinetic similarity of SCT630 to adalimumab.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Beijing SHIJITAN Hospital

Beijing, Beijing Municipality, 100038, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCT630

Drug

SCT630 single s.c. injection

adalimumab-EU source

Drug

adalimumab-EU source single s.c. injection

Primary outcomes

  1. AUC0-tz

    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

  2. Cmax

    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

Secondary outcomes

  1. AUC 0-∞

    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

  2. Tmax

    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

  3. t1/2

    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

  4. λz

    Time frame: Day 1 through Day 71

    λz of SCT630 and EU-licensed Humira

  5. CL

    Time frame: Day 1 through Day 71

    Clearance rate of the SCT630 and EU-licensed Humira

  6. Vd

    Time frame: Day 1 through Day 71

    Apparent volume of distribution (Vd) of the SCT630 and EU-licensed Humira

  7. Number (Proportion) of Subjects With Drug Related Adverse Events

    Time frame: Day 1 through Day 71

  8. Positive rate of ADA and NAb

    Time frame: Day 1 through Day 71

    Comparision of the positive rate of ADA and NAb between the SCT630 and EU-licensed Humira

Sponsors and collaborators

Lead sponsor

Sinocelltech Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2019
Registry last updated
Jan 29, 2021

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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