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NCT06182384CompletedPhase 1

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

A Single-center, Randomized, Open, Two-period, Two-sequence Crossover Clinical Study to Compare the Safety and Pharmacokinetics of SHR-1314 Injection in Healthy Subjects at Different Specifications Devices

Source: ClinicalTrials.gov · Last updated 14 Jun 2024

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
46 (actual)
First submitted
4 Dec 2023
Start date
24 Dec 2023
Primary completion date
13 May 2024
Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Diseases
Psoriasis
NCT number
NCT06182384

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 46
  • From 24 Dec 2023 to the primary completion date, 13 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Those who have participated in any clinical study for any drug or medical device within 3 months before screening
  • Those who have received live attenuated vaccine within 12 weeks prior to screening or plan to receive live attenuated vaccine during the trial.
  • Blood donation or blood loss ≥ 400 mL within 8 weeks prior to screening, or receiving blood transfusion within 8 weeks;
  • Had used other drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines and dietary supplements) in the 2 weeks before screening;
  • 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
  • History or evidence of ongoing alcohol or drug abuse, within the last six months before Baseline.
  • 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;

Other illness

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

Lab values

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

Other

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

Who the study is looking for

  • 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.
  • Both men and women are eligible, aged 18 to 45 years old (inclusive, as determined at the time of signing informed consent form).
  • Body mass index (BMI) is between 18 and 25 kg/m2 (inclusive), with male weight ≥ 50 kg and female weight ≥ 45 kg.
  • 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.

Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Second Hospital of Anhui Medical University
Coordinator of this site? Confirm its status
HefeiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.