Prevention of Graft Rejection After Organ TransplantationPhase 1NCT06090799

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3032 in Healthy Subjects

A Phase 1 study testing SHR-3032 in people with Prevention of Graft Rejection After Organ Transplantation, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single-center, double-blind, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3032 in healthy adults. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Prevention of Graft Rejection After Organ Transplantation
What is being tested?: SHR-3032
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6 participants
Where: 1 siteChina
Study dates: 29 Nov 2023to 8 Apr 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

The age when signing the informed consent form is between 18 and 55 years old (inclusive);
Male weight ≥ 50 kg and female weight ≥ 45 kg, body mass index (BMI) is between 19.0 ~ 28.0 kg/m2 (inclusive) during the screening period;
The subject has no plans to donate sperm or eggs from signing the informed consent form to 6 months following administration. Female subjects with reproductive potential must conduct a serum pregnancy test within 7 days before the first drug use, and the result is Negative. Fertile female subjects and male subjects whose partners are females of childbearing age must agree to comply with contraceptive requirements from signing the informed consent form to 6 months following administration;
Female subjects: non-pregnant or non-lactating;
The subject has a detailed understanding of the nature, significance, possible benefits, possible inconvenience, potential risks and discomfort of the study, can understand the procedures and methods of this study, and is willing to strictly abide by the requirements of the entire clinical study and voluntarily signed the informed consent.

Who cannot join

Previously or currently suffering from clinical acute and chronic diseases of circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, who are judged by the researchers to be inappropriate for enrollment;
During the screening period, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 times the upper limit of the normal range (ULN), or total bilirubin (TBIL) ≥ 1.5 times the ULN, or lymphocytes were lower than the lower limit of the normal range;
The subjects' medical history, symptoms and examination results at the time of screening suggest that they have active tuberculosis or latent tuberculosis;
Those who had chronic infection or recurrent infection and needed treatment within 12 months before screening;
People with hereditary bleeding or coagulation disorders, or a history of non-traumatic bleeding (bleeding requiring treatment);
Those who are at risk of thromboembolic events (such as thromboembolism in cardiovascular, cerebrovascular, peripheral blood vessels);

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Previous medical history of torsade de pointes, symptomatic ventricular arrhythmia, or personal or family history of short QT syndrome or long QT syndrome;
Patients with abnormal and clinically significant hyperkalemia and hypokalemia judged by the investigator;
People who are known to have a history of allergies to this product, its excipients, similar drugs, or allergic constitution (allergic to 2 or more drugs and food);
Those who have undergone major surgery within 3 months before screening, or those who have previously received surgery that may significantly affect the pharmacokinetic characteristics or safety evaluation of the investigational drug, or those who plan to undergo surgery during the study period;
Any drug that inhibits or induces liver metabolism of drug has been used within 1 month before administration (such as: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors- SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines);
Those who have been vaccinated within 1 month before screening or plan to be vaccinated during the study;
Those who have used any drugs or health products (including Chinese herbal medicines) within 7 half-lives or 14 days (whichever is longer) before the administration, or those who are known during the screening period may need to receive other drug treatments during the study;
Those who have participated in clinical trials and received experimental drugs within 3 months before screening, or plan to participate in other clinical trials during this study;
Those who have received any systemic glucocorticoid therapy within 3 months before screening;
Those who have received any of the following treatments at any time before: B cell targeted therapy; Abatacept;
Donate blood/blood loss ≥ 400 mL within 3 months before screening (except for female physiological blood loss), receive blood transfusion or use blood products, or plan to donate blood during the test or within 1 month after the end of the test;
Those who smoked more than 5 cigarettes per day on average within 3 months before screening, or who could not quit smoking during the study;
Regular drinkers within 3 months before screening (drinking more than 14 units of alcohol per week on average, 1 unit = 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine), or unable to stop drinking during the study;
Those who drank excessive tea, coffee or caffeinated beverages (average of more than 8 cups per day, 1 cup = 200 mL) within 3 months before screening;
Those who consumed special food (such as grapefruit, grapefruit juice or food/drink containing grapefruit juice, chocolate, tobacco, alcohol, caffeine and other food or drink) within 48 hours before administration;
Those who have special requirements for diet and cannot follow a unified diet;
Screening period or baseline examination results (vital signs, physical examination, 12-lead electrocardiogram, lateral chest X-ray, abdominal B-ultrasound, thyroid function, blood routine, urine routine, stool routine, blood biochemistry, coagulation function test) are abnormal and have clinical significance judged by the investigators;
One or more positive tests for hepatitis B surface antigen, hepatitis C virus antibody, syphilis or human immunodeficiency virus antibody;
Those who have a history of drug abuse or who are positive for drug abuse screening;
Alcohol breath screening results are positive;
Those who have difficulty in venous blood collection or who cannot tolerate venipuncture, or those who have a history of fainting of needles and blood;
The subject may not be able to complete the study due to other reasons or the investigators considers that he is not suitable for inclusion.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University Third Hospital
Beijing, Beijing Municipality, 100191

Other trials in China

About this study

Official title: A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3032 Following Single Intravenous Administration in Healthy Subjects

This is a single-center, double-blind, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3032 in healthy adults.

Conditions: Prevention of Graft Rejection After Organ Transplantation
Being tested: SHR-3032, SHR-3032 Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHR-3032Drug
Single dose at varying dosage levels depending on treatment assignment
SHR-3032 PlaceboDrug
Single dose at varying dosage levels depending on treatment assignment

Study groups in NCT06090799
Study group	Role	What they receive
Treatment group A	Experimental	SHR-3032 Receives: Drug: SHR-3032
Treatment group B	Placebo comparator	SHR-3032 Placebo Receives: Drug: SHR-3032 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence and severity of adverse events/serious adverse events
Measured: From ICF signing date to day 99
Pharmacokinetic parameter of SHR-3032: Cmax
Measured: 0 minute to day 99 after administration
Pharmacokinetic parameter of SHR-3032: AUC0-t
Measured: 0 minute to day 99 after administration
Pharmacokinetic parameter of SHR-3032: AUC0-∞
Measured: 0 minute to day 99 after administration
Pharmacokinetic parameter of SHR-3032: Tmax
Measured: 0 minute to day 99 after administration
Pharmacokinetic parameter of SHR-3032: t1/2
Measured: 0 minute to day 99 after administration
Pharmacokinetic parameter of SHR-3032: CL
Measured: 0 minute to day 99 after administration
Pharmacokinetic parameter of SHR-3032: Vss
Measured: 0 minute to day 99 after administration

Secondary outcomes (2)

The percentage of target receptor occupancy
Measured: 0 minute to day 99 after administration
The incidence of positive ADA
Measured: 0 minute to day 99 after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Nov 20238 Apr 2024

First posted19 Oct 2023
Study start29 Nov 2023
Primary completion28 Mar 2024
Study completion8 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prevention of Graft Rejection After Organ 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
Model description: SHR-3032 for dose escalation
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06090799
Sponsor's protocol ID: SHR-3032-101
Status last verified: Oct 2024
First submitted: 13 Oct 2023
Last updated: 15 Oct 2024
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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3032 Following Single Intravenous Administration in Healthy Subjects
ClinicalTrials.gov ID: NCT06090799
Acronym / sponsor ID: SHR-3032-101
Conditions: Prevention of Graft Rejection After Organ Transplantation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: 29 Nov 2023 (actual)
Primary completion: 28 Mar 2024 (actual)
Study completion: 8 Apr 2024 (actual)
First posted: 19 Oct 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 single-center, double-blind, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3032 in healthy adults.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: SHR-3032 for dose escalation

Arm	Type	Receives
Treatment group A	Experimental	Drug: SHR-3032SHR-3032
Treatment group B	Placebo comparator	Drug: SHR-3032 PlaceboSHR-3032 Placebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

The age when signing the informed consent form is between 18 and 55 years old (inclusive);
Male weight ≥ 50 kg and female weight ≥ 45 kg, body mass index (BMI) is between 19.0 ~ 28.0 kg/m2 (inclusive) during the screening period;
The subject has no plans to donate sperm or eggs from signing the informed consent form to 6 months following administration. Female subjects with reproductive potential must conduct a serum pregnancy test within 7 days before the first drug use, and the result is Negative. Fertile female subjects and male subjects whose partners are females of childbearing age must agree to comply with contraceptive requirements from signing the informed consent form to 6 months following administration;
Female subjects: non-pregnant or non-lactating;
The subject has a detailed understanding of the nature, significance, possible benefits, possible inconvenience, potential risks and discomfort of the study, can understand the procedures and methods of this study, and is willing to strictly abide by the requirements of the entire clinical study and voluntarily signed the informed consent.

Key exclusion criteria (28 listed)

Previously or currently suffering from clinical acute and chronic diseases of circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, who are judged by the researchers to be inappropriate for enrollment;
During the screening period, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 times the upper limit of the normal range (ULN), or total bilirubin (TBIL) ≥ 1.5 times the ULN, or lymphocytes were lower than the lower limit of the normal range;
The subjects' medical history, symptoms and examination results at the time of screening suggest that they have active tuberculosis or latent tuberculosis;
Those who had chronic infection or recurrent infection and needed treatment within 12 months before screening;
People with hereditary bleeding or coagulation disorders, or a history of non-traumatic bleeding (bleeding requiring treatment);

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-3032Single dose at varying dosage levels depending on treatment assignment	Drug	Treatment group A
SHR-3032 PlaceboSingle dose at varying dosage levels depending on treatment assignment	Drug	Treatment group B

Primary outcome

The incidence and severity of adverse events/serious adverse events
Time frame: From ICF signing date to day 99
Pharmacokinetic parameter of SHR-3032: Cmax
Time frame: 0 minute to day 99 after administration
Pharmacokinetic parameter of SHR-3032: AUC0-t
Time frame: 0 minute to day 99 after administration
Pharmacokinetic parameter of SHR-3032: AUC0-∞
Time frame: 0 minute to day 99 after administration
Pharmacokinetic parameter of SHR-3032: Tmax
Time frame: 0 minute to day 99 after administration
Pharmacokinetic parameter of SHR-3032: t1/2
Time frame: 0 minute to day 99 after administration
Pharmacokinetic parameter of SHR-3032: CL
Time frame: 0 minute to day 99 after administration
Pharmacokinetic parameter of SHR-3032: Vss
Time frame: 0 minute to day 99 after administration

2 secondary outcomes

The percentage of target receptor occupancy
Time frame: 0 minute to day 99 after administration
The incidence of positive ADA
Time frame: 0 minute to day 99 after administration

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 15 Oct 2024.
Individual participant dataSharing planned: Undecided

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 testing SHR-3032 in people with Prevention of Graft Rejection After Organ 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 28 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 15 Oct 2024. 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. Some participants in this study may receive a placebo. 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?

The incidence and severity of adverse events/serious adverse events (time frame: From ICF signing date to day 99). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06090799.

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 15 Oct 2024.