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

Bioequivalence Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04527484
• Other study ID #: SHR-1314-105
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 20, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: August 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Qian Xu, Ph.D
• Phone: 0186 021-68868370
• Email: PRS_admin[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: March 30, 2021
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• SHR-1314
each group subjects will be given different formulations of SHR-1314

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	AUC0-8: Area under the serum concentration-time curve from time zero to infinity	Compare the AUC0-8 of 240mg subcutaneous injection of two specifications of SHR-1314 injection in healthy subjects	from Day1 to Day113
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Anti-drug Antibodies (ADAs)	Incidence of development of Anti-drug Antibodies (ADAs) during the course of the study.	from Day1 to Day113