A Clinical Study to Compare the Safety and Pharmacokinetics of SHR-1314 Injection in Healthy Subjects at Different Specifications Devices

NCT ID: NCT06182384

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-24
• Study Completion Date: 2024-05-13

Brief Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of SHR-1314 injection in healthy subjects at different specifications devices.

Conditions

Moderate-to-Severe Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence A

Group Type: EXPERIMENTAL

SHR-1314

Intervention Type: DRUG

Receive a single dose of 240mg SHR-1314 at every period (First period：1mL AI, injection two needles. Second period: 2mL AI, injection one needle).

Sequence B

Group Type: EXPERIMENTAL

SHR-1314

Intervention Type: DRUG

Receive a single dose of 240mg SHR-1314 at every period (First period：2mL AI, injection one needle. Second period: 1mL AI, injection two needles).

Interventions

SHR-1314

Receive a single dose of 240mg SHR-1314 at every period (First period：1mL AI, injection two needles. Second period: 2mL AI, injection one needle).

Intervention Type: DRUG

SHR-1314

Receive a single dose of 240mg SHR-1314 at every period (First period：2mL AI, injection one needle. Second period: 1mL AI, injection two needles).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntary signing of informed consent form before related activities of the experiment and understanding of the procedures and methods of the experiment, willing to strictly follow the clinical trial protocol to complete the experiment.

2. Both men and women are eligible, aged 18 to 45 years old (inclusive, as determined at the time of signing informed consent form).

3. Body mass index (BMI) is between 18 and 25 kg/m2 (inclusive), with male weight ≥ 50 kg and female weight ≥ 45 kg.

4. 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

1. Having a history of any clinically significant disease or condition that the investigator believes may affect the trial results, including but not limited to a history of cardiovascular, endocrine, neurological, digestive, urinary, hematological, immunological, metabolic diseases, or existing diseases in these systems.

2. Have a history of drug or other allergies, or are likely to be allergic to the investigational drug or any component of the investigational drug as determined by the investigator.

3. History or current infection with human immunodeficiency virus (HIV) or hepatitis C; or current hepatitis B infection or syphilis.

4. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years.

5. History of chronic or recurrent infectious disease, or evidence of active or latent tuberculosis infection.

6. Clinical symptoms, signs, laboratory tests, or X-rays suggest active or latent tuberculosis Tuberculosis infected persons;

7. Those who have participated in any clinical study for any drug or medical device within 3 months before screening

8. Those who have received live attenuated vaccine within 12 weeks prior to screening or plan to receive live attenuated vaccine during the trial.

9. Blood donation or blood loss ≥ 400 mL within 8 weeks prior to screening, or receiving blood transfusion within 8 weeks;

10. Venous blood collection difficulties or physical conditions can not withstand blood collection;

11. Had used other drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines and dietary supplements) in the 2 weeks before screening;

12. Current or past alcoholics (drinking more than 14 standard units per week) 1 Standard unit containing 14g of alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); Or who cannot abstain from alcohol during the trial;

13. The average daily smoking amount in the 3 months before the test was ≥ 10 cigarettes; Or cannot stop using any tobacco products during the trial

14. History or evidence of ongoing alcohol or drug abuse, within the last six months before Baseline.

15. Female and male subjects who are fertile (defined as having the physical conditions necessary to become pregnant) who plan to become pregnant or donate sperm/egg within 20 weeks of using the study drug (greater than 5 half-lives) or who do not wish to use contraception; Female subjects who are fertile but have not used contraception in the 30 days prior to randomization;

16. 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.

17. Subjects judged by the investigator as unsuitable for participating in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Countries

China

References

Dong Y, Gao X, Feng S, Lin L, Shen K, Hu W. Safety, pharmacokinetics, and bioequivalence of vunakizumab injection, a specific dermatitis drug, in healthy Chinese volunteers: an open-label, randomized, two-stage, two-sequence cross-over study. Expert Opin Drug Metab Toxicol. 2025 Sep;21(9):1117-1123. doi: 10.1080/17425255.2025.2558829. Epub 2025 Sep 15.

Reference Type: DERIVED

PMID: 40947125 (View on PubMed)

Other Identifiers

SHR-1314-106

Identifier Type: -

Identifier Source: org_study_id