Healthy VolunteersPhase 1NCT06995001
Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Injection of SHR-2173 in Healthy Subjects
A Phase 1 study testing SHR-2173 in people with Healthy Volunteers, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics and immunogenicity of a single dose of SHR-2173 by subcutaneous injection. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- SHR-2173
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2024to 28 Nov 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female between the ages of 18 and 45 years, inclusive;
- At least 50.0 kg for male subjects, 45.0 kg for female subjects, with a Body Mass Index (BMI) between 19.0-28.0 kg/m2 , inclusive (BMI = weight/height2 );
- Female subjects of childbearing potential or male subjects whose partners are women of childbearing must avoid sperm/ovum donation and adopt highly effective contraceptive measurements (non-pharmacological contraception is required during the trial period) from the time of signing the informed consent form until the final visit;
- Subjects who could understand the details, procedures, and possible adverse reactions of the trial before it begins and voluntarily sign a written informed consent form。
Who cannot join
- Subjects with a history of drug allergies, or those with an allergic constitution (e.g., allergic to two or more drugs, foods, or pollens), or those known to be allergic to the investigational drug (including excipients) or similar drugs;
- History or presence of any condition that may affect the safety or the pharmacokinetics of the investigational drug, including: immune system, respiratory system, hematological system (e.g., hemolytic reactions), circulatory system, digestive system, urinary system, nervous system, endocrine system, psychiatric disorders, metabolic disorders, or other conditions deemed unsuitable for participation in clinical trials;
- Presence of active infection;
- History of severe herpes virus infection, or history or presence of malignant tumors;
- History of risk factors for torsades de pointes ventricular tachycardia, such as unexplained syncope, confirmed long QT syndrome (including family history), heart failure, myocardial infarction, or angina pectoris;
- Subjects who have undergone major surgery within 3 months prior to screening, or surgery that may significantly affect the pharmacokinetics or safety evaluation of the investigational drug, or those planning to undergo surgery during the trial period.
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- Subjects who have used or are currently using any prescription drugs, over-the-counter medications, functional vitamins, health supplements, or herbal products within 2 weeks prior to dosing; or those planning to use other drugs during the trial period;
- Subjects who have been vaccinated within 30 days prior to dosing or plan to be vaccinated within 3 months after dosing.
- Subjects with a 12-lead ECG showing first-degree or higher atrioventricular block, atrial fibrillation or flutter, QTcF ≥450 ms, or other clinically significant abnormalities as judged by the investigator during the screening period;
- Subjects with clinically significant abnormalities in blood routine, urinalysis, blood biochemistry, coagulation function, physical examination, vital signs, chest X-ray, or abdominal ultrasound as judged by the investigator during the screening period;
- Subjects with positive results for hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody, or human immunodeficiency virus (HIV) during the screening period;
- Pregnant or lactating females, or subjects with a positive serum pregnancy test;
- Subjects with a positive tuberculosis infection screening test (interferon-gamma release assay, IGRA); IGRA includes but is not limited to QuantiFERON-TB Gold In-Tube (QFT-GIT) and T-SPOT.TB. If the IGRA result is indeterminate, retesting is allowed. Subjects with two indeterminate results will be considered positive.
- Subjects who participated in other clinical trials and used investigational drugs within 3 months prior to dosing, or whose last study ended less than 5 half-lives or the duration of biological effects (whichever is longer);
- Subjects who donated blood or lost ≥200 mL of blood (excluding menstrual blood loss in females) within 3 months prior to dosing, or received blood transfusions or blood products, or donated platelets within 2 weeks prior to dosing, or plan to donate blood during or within 3 months after the trial;
- Subjects who frequently consumed alcohol (i.e., more than 14 standard units per week [1 standard unit = 14 g of alcohol, e.g., 360 mL beer, 45 mL of 40% spirits, or 150 mL wine]) within 3 months prior to dosing, or cannot abstain from alcohol during the trial period; or subjects with a positive breath alcohol test at baseline;
- Subjects with a history of drug abuse or illicit drug use, or a positive drug abuse screening test at baseline;
- Subjects who smoked more than 5 cigarettes or equivalent tobacco products daily within 3 months prior to dosing;
- Subjects with abnormalities at the injection site, as judged by the investigator to be unsuitable for subcutaneous administration;
- Any other reasons deemed unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics and immunogenicity of a single dose of SHR-2173 by subcutaneous injection.
- Conditions
- Healthy Volunteers
- Being tested
- SHR-2173, SHR-2173 ；Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2173Drug
SHR-2173 injection dose 1；
SHR-2173 ；PlaceboDrug
SHR-2173 injection dose 2 ；Pacebo dose 2
SHR-2173 ；PlaceboDrug
SHR-2173 injection dose 3 ；Pacebo dose 3
SHR-2173 ；PlaceboDrug
SHR-2173 injection dose 4 ；Pacebo dose 4
SHR-2173 ；PlaceboDrug
SHR-2173 injection dose 5 ；Pacebo dose 5
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: SHR-2173 |
| Treatment group B | Experimental | Not described Receives: Drug: SHR-2173 ；Placebo |
| Treatment group C | Experimental | Not described Receives: Drug: SHR-2173 ；Placebo |
| Treatment group D | Experimental | Not described Receives: Drug: SHR-2173 ；Placebo |
| Treatment group E | Experimental | Not described Receives: Drug: SHR-2173 ；Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent Adverse Events (TEAE)
Measured: Day1~Day71
Secondary outcomes (8)
Cmax
Measured: Day1~Day71
AUC0-t
Measured: Day1~Day71
AUC0-∞
Measured: Day1~Day71
Tmax,
Measured: Day1~Day71
t1/2,
Measured: Day1~Day71
CLz/F,
Measured: Day1~Day71
Vz/F,
Measured: Day1~Day71
Immunogenicity ：Anti- SHR -2173 antibody (ADA)
Measured: Day1~Day71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start28 Apr 2024
- Primary completion28 Nov 2024
- Study completion28 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 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
- NCT06995001
- Sponsor's protocol ID
- SHR-2173-101
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 29 May 2025
- 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 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Injection of SHR-2173 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06995001
- Acronym / sponsor ID
- SHR-2173-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2024 (actual)
- Primary completion
- 28 Nov 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 29 May 2025 (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.
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics and immunogenicity of a single dose of SHR-2173 by subcutaneous injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-2173 |
| Treatment group B | Experimental | Drug: SHR-2173 ；Placebo |
| Treatment group C | Experimental | Drug: SHR-2173 ；Placebo |
| Treatment group D | Experimental | Drug: SHR-2173 ；Placebo |
| Treatment group E | Experimental | Drug: SHR-2173 ；Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female between the ages of 18 and 45 years, inclusive;
- At least 50.0 kg for male subjects, 45.0 kg for female subjects, with a Body Mass Index (BMI) between 19.0-28.0 kg/m2 , inclusive (BMI = weight/height2 );
- Female subjects of childbearing potential or male subjects whose partners are women of childbearing must avoid sperm/ovum donation and adopt highly effective contraceptive measurements (non-pharmacological contraception is required during the trial period) from the time of signing the informed consent form until the final visit;
- Subjects who could understand the details, procedures, and possible adverse reactions of the trial before it begins and voluntarily sign a written informed consent form。
Key exclusion criteria (20 listed)
- Subjects with a history of drug allergies, or those with an allergic constitution (e.g., allergic to two or more drugs, foods, or pollens), or those known to be allergic to the investigational drug (including excipients) or similar drugs;
- History or presence of any condition that may affect the safety or the pharmacokinetics of the investigational drug, including: immune system, respiratory system, hematological system (e.g., hemolytic reactions), circulatory system, digestive system, urinary system, nervous system, endocrine system, psychiatric disorders, metabolic disorders, or other conditions deemed unsuitable for participation in clinical trials;
- Presence of active infection;
- History of severe herpes virus infection, or history or presence of malignant tumors;
- History of risk factors for torsades de pointes ventricular tachycardia, such as unexplained syncope, confirmed long QT syndrome (including family history), heart failure, myocardial infarction, or angina pectoris;
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-2173SHR-2173 injection dose 1； | Drug | Treatment group A |
| SHR-2173 ；PlaceboSHR-2173 injection dose 2 ；Pacebo dose 2 | Drug | Treatment group B |
| SHR-2173 ；PlaceboSHR-2173 injection dose 3 ；Pacebo dose 3 | Drug | Treatment group C |
| SHR-2173 ；PlaceboSHR-2173 injection dose 4 ；Pacebo dose 4 | Drug | Treatment group D |
| SHR-2173 ；PlaceboSHR-2173 injection dose 5 ；Pacebo dose 5 | Drug | Treatment group E |
Primary outcome
Treatment-emergent Adverse Events (TEAE)
Time frame: Day1~Day71
8 secondary outcomes
Cmax
Time frame: Day1~Day71
AUC0-t
Time frame: Day1~Day71
AUC0-∞
Time frame: Day1~Day71
Tmax,
Time frame: Day1~Day71
t1/2,
Time frame: Day1~Day71
CLz/F,
Time frame: Day1~Day71
Vz/F,
Time frame: Day1~Day71
Immunogenicity ：Anti- SHR -2173 antibody (ADA)
Time frame: Day1~Day71
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 29 May 2025.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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-2173 in people with Healthy Volunteers, 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 4 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 29 May 2025. 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?
Treatment-emergent Adverse Events (TEAE) (time frame: Day1~Day71). 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 29 May 2025.