Clinical trial NCT04527484: A Bioequivalence Study to Compare Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bioequivalence
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-26
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility 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.

Primary outcomes:
measure: AUC0-last: Area under the serum concentration-time curve from time zero to the last measurable concentration
timeFrame: from Day1 to Day113
measure: Cmax: Observed maximum serum concentration
timeFrame: from Day1 to Day113
measure: AUC0-∞: Area under the serum concentration-time curve from time zero to infinity
timeFrame: from Day1 to Day113
Secondary outcomes:
measure: Tmax : Time at which observed maximum concentration occurs
timeFrame: from Day1 to Day113
measure: CL/F: Apparent clearance
timeFrame: from Day1 to Day113
measure: t1/2: Terminal half-life
timeFrame: from Day1 to Day113
measure: V/F:Apparent volume of distribution
timeFrame: from Day1 to Day113
measure: Incidence and severity of adverse events (AEs).
timeFrame: from Day1 to Day113
measure: Anti-drug Antibodies (ADAs)
timeFrame: from Day1 to Day113
Other outcomes:
Locations:
Study officials:
References: