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

Phase 1

• Conditions: Bioequivalence
• Interventions: Drug: SHR-1314

• Registration Number: NCT04527484
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08-20
• Study First Submitted: 2020-08-23
• Study First Submitted QC: 2020-08-23
• Last Update Submitted: 2020-08-23
• Study First Posted: 2020-08-26
• Last Update Posted: 2020-08-26
• Primary Completion: 2021-01-10
• Study Completion: 2021-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	SHR-1314	SHR-1314 Vial
Group B	SHR-1314	SHR-1314 PFS

Primary Outcome Measures

Name	Time	Method
AUC0-last: Area under the serum concentration-time curve from time zero to the last measurable concentration	from Day1 to Day113	Compare the AUC0-last of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
AUC0-∞: Area under the serum concentration-time curve from time zero to infinity	from Day1 to Day113	Compare the AUC0-∞ of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
Cmax: Observed maximum serum concentration	from Day1 to Day113	Compare the Cmax of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects

Secondary Outcome Measures

Name	Time	Method
t1/2: Terminal half-life	from Day1 to Day113	Compare the t1/2 of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
CL/F: Apparent clearance	from Day1 to Day113	Compare the CL/F of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
Incidence and severity of adverse events (AEs).	from Day1 to Day113	Compare Incidence and severity of AE at 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
Tmax : Time at which observed maximum concentration occurs	from Day1 to Day113	Compare the Tmax of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects
Anti-drug Antibodies (ADAs)	from Day1 to Day113	Incidence of development of Anti-drug Antibodies (ADAs) during the course of the study.
V/F:Apparent volume of distribution	from Day1 to Day113	Compare the V/F of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects