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A Bioequivalence Study to Compare Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04527484
Recruitment Status : Not yet recruiting
First Posted : August 26, 2020
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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Brief Summary:
This study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate bioequivalence of two formulations of SHR-1314. Subjects will be randomly assigned to the Vials group, the PFS group at a ratio of 1:1

Condition or disease Intervention/treatment Phase
Bioequivalence Drug: SHR-1314 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-center, Randomized, Parallel, Open-label , Bioequivalence Study to Compare the Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects
Estimated Study Start Date : August 20, 2020
Estimated Primary Completion Date : January 10, 2021
Estimated Study Completion Date : March 30, 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group A
SHR-1314 Vial
 Drug: SHR-1314
each group subjects will be given different formulations of SHR-1314
Active Comparator: Group B
SHR-1314 PFS
 Drug: SHR-1314
each group subjects will be given different formulations of SHR-1314


Outcome Measures
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Primary Outcome Measures :
  1. AUC0-last: Area under the serum concentration-time curve from time zero to the last measurable concentration [ Time Frame: from Day1 to Day113 ]
    Compare the AUC0-last of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects

  2. Cmax: Observed maximum serum concentration [ Time Frame: from Day1 to Day113 ]
    Compare the Cmax of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects

  3. AUC0-∞: Area under the serum concentration-time curve from time zero to infinity [ Time Frame: from Day1 to Day113 ]
    Compare the AUC0-∞ of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects


Secondary Outcome Measures :
  1. Tmax : Time at which observed maximum concentration occurs [ Time Frame: from Day1 to Day113 ]
    Compare the Tmax of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects

  2. CL/F: Apparent clearance [ Time Frame: from Day1 to Day113 ]
    Compare the CL/F of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects

  3. t1/2: Terminal half-life [ Time Frame: from Day1 to Day113 ]
    Compare the t1/2 of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects

  4. V/F:Apparent volume of distribution [ Time Frame: from Day1 to Day113 ]
    Compare the V/F of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects

  5. Incidence and severity of adverse events (AEs). [ Time Frame: from Day1 to Day113 ]
    Compare Incidence and severity of AE at 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects

  6. Anti-drug Antibodies (ADAs) [ Time Frame: from Day1 to Day113 ]
    Incidence of development of Anti-drug Antibodies (ADAs) during the course of the study.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed.Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations
  • Men or women at least 18 years and no more than 45 years of age at time of screening.
  • Men with a body weight ≥50 kg or women with a body weight ≥45kg, with BMI range from 18 to 25.
  • Subjects with normal physical examination results and with normal laboratory results (blood, chemistry, urine, drug screening, coagulation function test), ECG and X-ray chest test are normal or with certain abnormal without clinical significance.

Exclusion Criteria:

  • Presence of significant medical problems, with investigator's judge that not proper to participate clinical study
  • History of hypersensitivity to any of study drug constituent
  • History or current infection with human immunodeficiency virus (HIV) or hepatitis C; or current hepatitis B infection or syphilis
  • History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years
  • History of chronic or recurrent infectious disease, or evidence of active or latent tuberculosis infection.
  • Those who have participated in any clinical study for any drug or medical device within 3 months before screening
  • Those who have been vaccinated with live attenuated vaccine within 12 weeks prior to screening
  • History or evidence of ongoing alcohol or drug abuse, within the last six months before Baseline.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
  • Subjects judged by the investigator as unsuitable for participating in this study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527484


Contacts
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Contact: Qian Xu, Ph.D 0186 021-68868370 PRS_admin@hrglobe.cn
Contact: Jianjun Zou, Ph.D 0186 021-68868370 PRS_admin@hrglobe.cn

Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
More Information
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04527484    
Other Study ID Numbers: SHR-1314-105
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No