A Clinical Study Comparing the Relative Bioavailability and Safety of SHR-3167 Injection
A Randomized, Parallel, Open-label Clinical Study on the Bioavailability and Safety of Different Specifications of SHR-3167 Injection in Healthy Subjects
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Yanli Dong
- Phone Number: +86-0518-82342973
- Email: yanli.dong@hengrui.com
Study Contact Backup
- Name: Weijie Kong
- Phone Number: +86-0518-82342973
- Email: weijie.kong.wk1@hengrui.com
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410008
- Recruiting
- Xiangya Hospital, Central South University
-
Contact:
- Gan Zhou
- Phone Number: +86-0731-89753401
- Email: zhougan77@163.com
-
Principal Investigator:
- Gan Zhou
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female: 18 years old to 55 years old (on the day of signing the informed consent form).
- For healthy subjects, the body mass index (BMI) should be between 19.0 kg/m² and 26.0 kg/m², and the weight of men should be ≥ 50 kg and that of women ≥ 45 kg.
- Those who show no abnormalities through physical examination, vital signs, 12-lead electrocardiogram, frontal and lateral chest radiographs and laboratory tests, or have minor abnormalities but are judged by the researcher to have no clinical significance.
- Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must have no plans for conception or sperm/egg donation from the time of signing the informed consent form until 4 months after the last dose, and must voluntarily refrain from unprotected sexual activity within 14 days before the screening period and use effective contraceptive measures (including partners) during the study period; female subjects of childbearing potential must have no unprotected sexual activity in the past 14 days, have a negative pregnancy test during the screening period, and not be in the lactation period.
- During the screening process, the fasting blood glucose should be between 3.9 mmol/L and 6.1 mmol/L, and the glycated hemoglobin (HbA1c) should be no more than 6.0%.
- Understand the research procedures and methods, voluntarily participate and have the ability to comply with the requirements of the trial protocol to complete this trial, and sign the informed consent form in person.
Exclusion Criteria:
- Those with a history of frequent allergies or allergic diseases, or those who, as judged by the researcher, may be allergic to the study drug or its components or foods, etc.
- Those who have previously suffered from respiratory system, circulatory system, digestive system, urinary system, mental, nervous system, blood system, endocrine system, immune system or malignant tumor diseases, and who, based on the investigator's judgment, are not suitable to participate in this trial.
- Exclude those who had severe infections, severe injuries or surgeries within the previous 12 weeks, or those who plan to undergo surgery during the trial.
- Exclude those who have participated in any clinical trials of other drugs or medical devices within the previous 3 months prior to screening, or those who are still within 5 half-lives of the trial drug at the time of screening (whichever is longer).
- Exclude those who have used any medication (including prescription drugs, over-the-counter drugs, herbal medicines, patent medicines, health supplements, etc.) within the previous 2 weeks up to the time of randomization.
- Positive results were obtained for hepatitis B surface antigen (HBsAg), HIV antibody, Treponema pallidum specific antibody, or hepatitis C virus antibody tests; or the investigator judged that the subject was in the latent or active stage of the aforementioned infections.
- Exclude those who have a history of blood donation within the past 12 weeks, or have suffered from severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within the past 12 weeks.
- Those who received live (attenuated) vaccines within the previous 1 month or are scheduled to receive such vaccines during the trial process.
- Those who have a history of drug use or substance abuse; or those who tested positive for drugs in the baseline visit.
- Those who have difficulty in venous blood collection or whose physical condition does not allow for blood collection; or those who are expected not to comply well with the protocol or complete the entire trial follow-up.
- Persons with incomplete civil capacity and without a valid guardian.
- The researchers determined that any physical or psychological condition or illness that might increase the risk of the trial, affect the subjects' compliance with the protocol, or prevent the subjects from completing the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: SHR-3167 Injection - Specification A Group
|
SHR-3167 injection, different specifications.
|
|
Experimental: SHR-3167 Injection - Specification B Group
|
SHR-3167 injection, different specifications.
|
|
Experimental: SHR-3167 Injection - Specification C Group
|
SHR-3167 injection, different specifications.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The maximum plasma concentration (Cmax)
Time Frame: Day 1 - Day 71.
|
Day 1 - Day 71.
|
|
The area under the blood drug concentration-time curve corresponding from time 0 to the last quantifiable concentration time (AUC0-t)
Time Frame: Day 1 - Day 71.
|
Day 1 - Day 71.
|
|
The area under the blood drug concentration-time curve from time 0 to infinity (AUC0-∞)
Time Frame: Day 1 - Day 71.
|
Day 1 - Day 71.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to maximum plasma concentration (Tmax)
Time Frame: Day 1 - Day 71.
|
Day 1 - Day 71.
|
|
Terminal half-life (t1/2)
Time Frame: Day 1 - Day 71.
|
Day 1 - Day 71.
|
|
Apparent volume of distribution (Vz/F)
Time Frame: Day 1 - Day 71.
|
Day 1 - Day 71.
|
|
Safety: Incidence and severity of adverse events (AEs)
Time Frame: Day 1 - Day 71.
|
Day 1 - Day 71.
|
|
Anti-SHR-3167 antibody (ADA)
Time Frame: Day 1; Day 22; Day 71.
|
Day 1; Day 22; Day 71.
|
|
Apparent clearance (CL/F)
Time Frame: Day 1 - Day 71.
|
Day 1 - Day 71.
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- SHR-3167-106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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