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

A Single-center, Randomized, Parallel, Open-label , Bioequivalence Study to Compare the Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects

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

Study Overview

• Status: Unknown
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: SHR-1314

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qian Xu, Ph.D; Phone Number: 0186 021-68868370; Email: PRS_admin@hrglobe.cn
• Study Contact Backup: Name: Jianjun Zou, Ph.D; Phone Number: 0186 021-68868370; Email: PRS_admin@hrglobe.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 20, 2020
• Primary Completion (ANTICIPATED): January 10, 2021
• Study Completion (ANTICIPATED): March 30, 2021

Study Registration Dates

• First Submitted: August 23, 2020
• First Submitted That Met QC Criteria: August 23, 2020
• First Posted (ACTUAL): August 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 23, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SHR-1314-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No