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

NCT04527484 | Unknown Phase 1 FDA Drug

• 1 other identifier: SHR-1314-105
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Tmax : Time at which observed maximum concentration occurs

  from Day1 to Day113

• CL/F: Apparent clearance

  from Day1 to Day113

• t1/2: Terminal half-life

  from Day1 to Day113

• V/F:Apparent volume of distribution

  from Day1 to Day113

• Incidence and severity of adverse events (AEs).

  from Day1 to Day113

Study Arms (2)

Group A

ACTIVE COMPARATOR

SHR-1314 Vial

Drug: SHR-1314

Group B

ACTIVE COMPARATOR

SHR-1314 PFS

Drug: SHR-1314

Interventions

SHR-1314 DRUG

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

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Central Study Contacts

Qian Xu, Ph.D

CONTACT

0186 021-68868370; PRS_admin@hrglobe.cn

Jianjun Zou, Ph.D

CONTACT

0186 021-68868370; PRS_admin@hrglobe.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: August 26, 2020
• Study Start: August 20, 2020
• Primary Completion: January 10, 2021
• Study Completion: March 30, 2021
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share