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Completed

NCT Number: NCT04772365

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects

This is a single center, randomized, double-blind, placebo-controlled, single and multiple dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous administered SHR-1819 in healthy subjects

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Third Xiangya Hospital of Central South University

Changsha, 410013, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent.
  • Be able to comply with all the requirements and able to complete the study.
  • Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
  • No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests.
  • Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after IP administration.

Exclusion criteria

  • Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening;
  • Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form), or in the follow-up period of a clinical study
  • Severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial
  • Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response

Treatment and study plan

SHR-1819

Drug

SHR-1819 will be subcutaneously administered with different dose levels;

Placebo

Drug

Placebo will be subcutaneously administered with different dose levels;

Primary outcomes

  1. Adverse events

    Time frame: Start of Treatment to end of study(about 13 weeks)

    Incidence and severity of adverse events

Secondary outcomes

  1. Pharmacokinetics-AUC0-last

    Time frame: Start of Treatment to end of study (about 13 weeks)

    Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration

  2. Pharmacokinetics-AUC0-inf

    Time frame: Start of Treatment to end of study (approximately 13 weeks)

    Area under the concentration-time curve from time 0 to infinity after SHR-1819 administration

  3. Pharmacokinetics-Tmax

    Time frame: Up to 13 weeks

    Time to Cmax of SHR-1819

  4. Pharmacokinetics-Cmax

    Time frame: Up to 13 weeks

    Maximum observed concentration of SHR-1819

  5. Pharmacokinetics-CL/F

    Time frame: Up to 13 weeks

    Apparent clearance of SHR-1819

  6. Pharmacokinetics-Vz/F

    Time frame: Up to 13 weeks

    Apparent volume of distribution during terminal phase of SHR-1819

  7. Pharmacokinetics-t1/2

    Time frame: Up to 13 weeks

    Terminal elimination half-life of SHR-1819

  8. Change from baseline to end of treatment for Thymus and activation-regulated chemokine(TARC/CCL17)

    Time frame: Up to 13 weeks

    Thymus and activation-regulated chemokine(TARC/CCL17)

  9. Change from baseline to end of treatment for IgE

    Time frame: Up to 13 weeks

    IgE

  10. Immunogenicy of SHR-1819 after administration

    Time frame: Up to 13 weeks]

    Anti-drug antibody

  11. Pharmacokinetics-AUCtau for multi-dose

    Time frame: Start of Treatment to end of study (about 13 weeks)

    Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration

  12. Pharmacokinetics- Ctrough for multi-dose

    Time frame: Up to 13 weeks

    Minimum observed concentration of SHR-1819

  13. Pharmacokinetics- Racc for multi-dose

    Time frame: Up to 13 weeks

    Accumulation ratio of SHR-1819

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered SHR-1819 in Healthy Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2021
Registry last updated
Nov 29, 2022

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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