Kidney TransplantationPhase 1NCT05948059
Safety and Tolerance of Increased Doses of SHR-2106 Injection in Healthy Subjects
A Phase 1 study of Kidney Transplantation, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplantation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2023to 10 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
- 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);
Show all 20Show fewer
- 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;
- Systolic blood pressure (SBP) before screening or administration: SBP ≥ 140 mmHg or < 90 mmHg; diastolic blood pressure (DBP) :D BP≥ 90 mmHg or < 50 mmHg;
- Glutaminase (AST) or alanine aminotransferase (ALT) at screening≥ 2 times the upper limit of normal range (ULN), or total bilirubin ≥ 1.5 times ULN
- Those with abnormal coagulation function and clinically significant, or those who have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, or those who need to receive preventive anticoagulation therapy during the test
- Those at risk of thromboembolic events (such as history of thromboembolism, cardiovascular disease, diabetes, recurrent spontaneous miscarriage, dyslipidemia);
- Abnormal and clinically significant 12-lead ECG results before screening or administration (e.g., male QTcF> 450 ms; QTcF for women >470 ms);
- Those who are positive for urine drug screening during the screening period; or those with a history of substance abuse within the previous 2 years of screening;
- Those who are positive for infectious disease screening (including hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, syphilis antibody) during the screening period;
- Those who received live (attenuated) vaccine within 4 weeks before screening or planned to be vaccinated during the trial;
- Those who plan to take any prescription drug, over-the-counter drug or Chinese herbal medicine that is not the test drug of the study during the screening period or 1 month before administration or within 5 half-lives of the drug (whichever is longer), or plan to take any nutritional supplement during the trial period that is not the test drug of the study (except for occasional use of acetaminophen in the recommended dose (the total amount of medication for one day does not exceed 2 g and the continuous dose does not exceed three days)) or plan to take any nutritional supplement during the trial period;
- Those who have participated in other clinical trials or within the 5 half-lives of the investigational drug within 3 months before screening (subject to the intervention of the investigational drug or medical device, whichever is longer);
- Have received any of the following therapies at any time: a) B-cell targeted therapy (e.g., rituximab, other anti-CD20 drugs, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS receptor fusion protein [BR3], TACI-Fc); b) Abatacept;
- Any physical or mental illness or condition that, as determined by the study physician, may increase the risk of the trial, affect the subject's adherence to the protocol, or affect the subject's completion of the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The third xiangya hospital of central south univercity
Changsha, Hunan, 410013
About this study
Official title: A Phase I Clinical Study on Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2106 After a Single Intravenous or Subcutaneous Administration of SHR-2106 in Healthy Subjects
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.
- Conditions
- Kidney Transplantation
- Being tested
- SHR-2106 injection or placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2106 injection or placeboDrug
starting dose from 50 mg
SHR-2106 injection or placeboDrug
starting dose from 300 mg
| Study group | Role | What they receive |
|---|---|---|
| Part 1: SHR-2106 injection or placebo single dose, iv | Experimental | Not described Receives: Drug: SHR-2106 injection or placebo |
| Part 2: SHR-2106 injection or placebo single dose, sc | Experimental | Not described Receives: Drug: SHR-2106 injection or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the incidence and severity of adverse events in healthy subjects after single dose of SHR-2106 injection
Measured: About 6 months from the first medication to the evaluation
Secondary outcomes (7)
Assess the concentration of SHR-2106 in plasma
Measured: About 6 months after the first dose
Evaluation of AUC0-t of SHR-2106 in plasma
Measured: About 6 months after the first dose
Evaluation of AUC0-∞ of SHR-2106 in plasma
Measured: About 6 months after the first dose
Evaluation of Tmax of SHR-2106 in plasma
Measured: About 6 months after the first dose
Evaluation of Cmax of SHR-2106 in plasma
Measured: About 6 months after the first dose
Evaluation of t1/2 of SHR-2106 in plasma
Measured: About 6 months after the first dose
To assess incidence of ADA following a single intravenous of SHR-2106 in healthy subjects
Measured: About 6 months after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start11 Jul 2023
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948059
- Sponsor's protocol ID
- SHR-2106-101
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study on Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2106 After a Single Intravenous or Subcutaneous Administration of SHR-2106 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05948059
- Acronym / sponsor ID
- SHR-2106-101
- Conditions
- Kidney Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: SHR-2106 injection or placebo single dose, iv | Experimental | Drug: SHR-2106 injection or placebo |
| Part 2: SHR-2106 injection or placebo single dose, sc | Experimental | Drug: SHR-2106 injection or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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);
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-2106 injection or placebostarting dose from 50 mg | Drug | Part 1: SHR-2106 injection or placebo single dose, iv |
| SHR-2106 injection or placebostarting dose from 300 mg | Drug | Part 2: SHR-2106 injection or placebo single dose, sc |
Primary outcome
Assess the incidence and severity of adverse events in healthy subjects after single dose of SHR-2106 injection
Time frame: About 6 months from the first medication to the evaluation
7 secondary outcomes
Assess the concentration of SHR-2106 in plasma
Time frame: About 6 months after the first dose
Evaluation of AUC0-t of SHR-2106 in plasma
Time frame: About 6 months after the first dose
Evaluation of AUC0-∞ of SHR-2106 in plasma
Time frame: About 6 months after the first dose
Evaluation of Tmax of SHR-2106 in plasma
Time frame: About 6 months after the first dose
Evaluation of Cmax of SHR-2106 in plasma
Time frame: About 6 months after the first dose
Evaluation of t1/2 of SHR-2106 in plasma
Time frame: About 6 months after the first dose
To assess incidence of ADA following a single intravenous of SHR-2106 in healthy subjects
Time frame: About 6 months after the first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Kidney Transplantation, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the incidence and severity of adverse events in healthy subjects after single dose of SHR-2106 injection (time frame: About 6 months from the first medication to the evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.