Safety and Tolerance of Increased Doses of SHR-2106 Injection in Healthy Subjects (NCT05948059) | Clinical Trial Compass
UnknownPhase 1
Safety and Tolerance of Increased Doses of SHR-2106 Injection in Healthy Subjects
China58 participantsStarted 2023-07-11
Plain-language summary
This is a randomized, double-blind, placebo-controlled phase I clinical study with the primary objective of evaluating the safety and tolerability of SHR-2106 in healthy subjects after a single intravenous or subcutaneous administration.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Obtain informed consent prior to the commencement of any activities related to the trial, have a full understanding of the purpose and significance of the trial, and be willing to comply with the trial protocol;
✓. Age 18 \~ 55 years old (including boundary value), male or female;
✓. Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) = weight (kg) / height 2 (m2), BMI in the range of 19 \~ 28 kg/m2 (including boundary value);
✓. Random pre-physical examination, vital signs, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), thyroid function, chest radiograph, 12-lead ECG results are normal or abnormal and have no clinical significance;
✓. Subjects and their partners who have no fertility plan and voluntarily take highly effective contraception during the study period to the last follow-up of the trial (the last follow-up time between dose groups is shown in Table 9), 6 months (female subjects receiving SHR-2106) or 3 months (male subjects receiving SHR-2106) and voluntarily take highly effective contraception (see Annex 1 of the protocol for specific contraceptive measures), female subjects must have a negative serum pregnancy test and be non-lactating.
Exclusion criteria
✕. The subject's medical history, symptoms and examination results at the time of screening suggest active tuberculosis or latent tuberculosis. All participants will be screened for TB status by γ interferon gamma release assay (IGRA) and chest radiograph (x-ray). Participants who underwent IGRA and x-ray examination within 1 month prior to screening may, at the discretion of the investigator, not repeat IGRA and x-ray at screening;
✕. History of severe cardiovascular, liver, kidney, digestive tract, psychiatric, hematology, metabolic and other diseases (within 5 years);
What they're measuring
1
Assess the incidence and severity of adverse events in healthy subjects after single dose of SHR-2106 injection
Timeframe: About 6 months from the first medication to the evaluation
✕. Those who have serious infection, severe trauma or major surgery within 6 months before screening or administration; those who plan to undergo surgery during the trial;
✕. Those who have chronic infection or recurrent infection within 12 months before screening and need treatment;
✕. Those who donated blood or lost a total of ≥200 mL within 1 month before screening or administration, or ≥ 400 mL of blood donation or blood loss within 3 months before administration, or who received blood transfusion within 2 months;
✕. Those who have a history of allergies to two or more foods and drugs; or a known history of allergy to the study drug or any component of the study drug (see Annex 2 of the protocol for injectable ingredients);
✕. History of tobacco addiction within 3 months before screening, defined as: an average of more than 5 cigarettes smoked per day; or those who are unable to comply with the no-smoking requirements during the study;
✕. Alcoholics within 3 months before screening (1 day intake of alcohol more than 15 g for women, more than 25 g for men \[5 g of alcohol is equivalent to 150 mL of beer, 50 mL of wine or about 17 mL of low-alcohol liquor\], more than 2 times a week) or positive alcohol breath test at baseline;