CompletedPhase 1

Safety and Tolerance of Increased Doses of SHR-2106 Injection in Healthy Subjects

China52 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 range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT05948059

SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-10

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