Chinese Healthy Adult SubjectsPhase 1NCT07232758
Safety, Tolerability and Pharmacokinetic Studies of HRS-2183 for Injection in Healthy Chinese Subjects After Single and Multiple Administration
A Phase 1 study testing HRS-2183 in people with Chinese Healthy Adult Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study mainly evaluated the safety and tolerability, as well as the pharmacokinetic characteristics, of the injectable drug HRS-2183 after single and multiple administrations in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chinese Healthy Adult Subjects
- What is being tested?
- HRS-2183
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2025to 9 Jan 2026
- 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 and female subjects, aged 18 to 45 years.
- Body weight and Body Mass Index (BMI) within a specified range (e.g., BMI 19.0-26.0 kg/m²).
- Agreement to use highly effective contraception during the study period and for a specified duration after the last dose. No plans for pregnancy, sperm/egg donation.
- Voluntarily provides written informed consent to participate in the study.
Who cannot join
- History of significant allergies to any food or drug, especially to the investigational product, its components, or drugs of a similar class.
- History or current presence of any clinically significant disease in major organ systems (e.g., cardiovascular, hepatic, renal, neurological, etc.).
- Any clinically significant abnormalities found during screening assessments (including physical examination, vital signs, and laboratory tests).
- Clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening.
- Evidence of impaired renal function based on laboratory tests (e.g., eGFR, serum creatinine).
- Positive screening for specified infectious diseases (e.g., HIV, HBV, HCV, Syphilis).
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- Use of any medication (including prescription, OTC, and herbal) within a specified period before the study.
- Excessive consumption of certain beverages (e.g., caffeine, grapefruit juice) or inability to adhere to dietary restrictions.
- History of major surgery within the past 3 months or planned surgery during the study period.
- Participation in another clinical trial within the past 3 months.
- Significant blood loss, blood donation, or transfusion within the past 3 months.
- History of excessive alcohol consumption or unwillingness to abstain during the study.
- History of heavy smoking or unwillingness to abstain during the study.
- History of drug abuse or positive drug screening test.
- Inability to tolerate venous access or history of fainting during blood draws.
- Inability to comply with the standardized diet provided during the study.
- Any other reason that, in the opinion of the investigator, makes the subject unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study mainly evaluated the safety and tolerability, as well as the pharmacokinetic characteristics, of the injectable drug HRS-2183 after single and multiple administrations in healthy subjects.
- Conditions
- Chinese Healthy Adult Subjects
- Being tested
- HRS-2183, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-2183Drug
HRS-2183
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A:HRS-2183 | Experimental | Not described Receives: Drug: HRS-2183 |
| Treatment group B:placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of any adverse events
Measured: Evaluation was performed up to the seventh day / the 16th day
Secondary outcomes (22)
Tmax (Pharmacokinetic Parameters after a Single Dose)
Measured: Evaluation was performed up to the third day
Cmax(Pharmacokinetic Parameters after a Single Dose)
Measured: Evaluation was performed up to the third day
AUC0-t(Pharmacokinetic Parameters after a Single Dose)
Measured: Evaluation was performed up to the third day
AUC0-∞(Pharmacokinetic Parameters after a Single Dose)
Measured: Evaluation was performed up to the third day
t1/2(Pharmacokinetic Parameters after a Single Dose)
Measured: Evaluation was performed up to the third day
CLz(Pharmacokinetic Parameters after a Single Dose)
Measured: Evaluation was performed up to the third day
Vz(Pharmacokinetic Parameters after a Single Dose)
Measured: Evaluation was performed up to the third day
Ae0-t(Pharmacokinetic Parameters after a Single Dose)
Measured: Evaluation was performed up to the third day
Fe0-t(Pharmacokinetic Parameters after a Single Dose)
Measured: Evaluation was performed up to the third day
CLr(Pharmacokinetic Parameters after a Single Dose)
Measured: Evaluation was performed up to the third day
Tmax(Pharmacokinetic Parameters after Multiple Doses)
Measured: Evaluation was performed up to the 12th day
Cmin,ss(Pharmacokinetic Parameters after Multiple Doses)
Measured: Evaluation was performed up to the 12th day
Cmax,ss(Pharmacokinetic Parameters after Multiple Doses)
Measured: Evaluation was performed up to the 12th day
Cav(Pharmacokinetic Parameters after Multiple Doses)
Measured: Evaluation was performed up to the 12th day
AUC0-t,ss(Pharmacokinetic Parameters after Multiple Doses)
Measured: Evaluation was performed up to the 12th day
AUC0-τ,ss(Pharmacokinetic Parameters after Multiple Doses)
Measured: Evaluation was performed up to the 12th day
AUC0-∞,ss(Pharmacokinetic Parameters after Multiple Doses)
Measured: Evaluation was performed up to the 12th day
t1/2(Pharmacokinetic Parameters after Multiple Doses)
Measured: Evaluation was performed up to the 12th day
CLss(Pharmacokinetic Parameters after Multiple Doses)
Measured: Evaluation was performed up to the 12th day
Vss(Pharmacokinetic Parameters after Multiple Doses)
Measured: Evaluation was performed up to the 12th day
Rac(Pharmacokinetic Parameters after Multiple Doses)
Measured: Evaluation was performed up to the 12th day
DF(Pharmacokinetic Parameters after Multiple Doses)
Measured: Evaluation was performed up to the 12th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start30 Oct 2025
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chinese Healthy Adult SubjectsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232758
- Sponsor's protocol ID
- HRS-2183-102
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 8 Sep 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetic Studies of HRS-2183 for Injection in Healthy Chinese Subjects After Single and Multiple Administration
- ClinicalTrials.gov ID
- NCT07232758
- Acronym / sponsor ID
- HRS-2183-102
- Conditions
- Chinese Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 18 Nov 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.
This study mainly evaluated the safety and tolerability, as well as the pharmacokinetic characteristics, of the injectable drug HRS-2183 after single and multiple administrations in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A:HRS-2183 | Experimental | Drug: HRS-2183 |
| Treatment group B:placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects, aged 18 to 45 years.
- Body weight and Body Mass Index (BMI) within a specified range (e.g., BMI 19.0-26.0 kg/m²).
- Agreement to use highly effective contraception during the study period and for a specified duration after the last dose. No plans for pregnancy, sperm/egg donation.
- Voluntarily provides written informed consent to participate in the study.
Key exclusion criteria (17 listed)
- History of significant allergies to any food or drug, especially to the investigational product, its components, or drugs of a similar class.
- History or current presence of any clinically significant disease in major organ systems (e.g., cardiovascular, hepatic, renal, neurological, etc.).
- Any clinically significant abnormalities found during screening assessments (including physical examination, vital signs, and laboratory tests).
- Clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening.
- Evidence of impaired renal function based on laboratory tests (e.g., eGFR, serum creatinine).
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 |
|---|---|---|
| HRS-2183HRS-2183 | Drug | Treatment group A:HRS-2183 |
| Placeboplacebo | Drug | Treatment group B:placebo |
Primary outcome
Incidence and severity of any adverse events
Time frame: Evaluation was performed up to the seventh day / the 16th day
22 secondary outcomes
Tmax (Pharmacokinetic Parameters after a Single Dose)
Time frame: Evaluation was performed up to the third day
Cmax(Pharmacokinetic Parameters after a Single Dose)
Time frame: Evaluation was performed up to the third day
AUC0-t(Pharmacokinetic Parameters after a Single Dose)
Time frame: Evaluation was performed up to the third day
AUC0-∞(Pharmacokinetic Parameters after a Single Dose)
Time frame: Evaluation was performed up to the third day
t1/2(Pharmacokinetic Parameters after a Single Dose)
Time frame: Evaluation was performed up to the third day
CLz(Pharmacokinetic Parameters after a Single Dose)
Time frame: Evaluation was performed up to the third day
Vz(Pharmacokinetic Parameters after a Single Dose)
Time frame: Evaluation was performed up to the third day
Ae0-t(Pharmacokinetic Parameters after a Single Dose)
Time frame: Evaluation was performed up to the third day
Fe0-t(Pharmacokinetic Parameters after a Single Dose)
Time frame: Evaluation was performed up to the third day
CLr(Pharmacokinetic Parameters after a Single Dose)
Time frame: Evaluation was performed up to the third day
Tmax(Pharmacokinetic Parameters after Multiple Doses)
Time frame: Evaluation was performed up to the 12th day
Cmin,ss(Pharmacokinetic Parameters after Multiple Doses)
Time frame: Evaluation was performed up to the 12th day
Cmax,ss(Pharmacokinetic Parameters after Multiple Doses)
Time frame: Evaluation was performed up to the 12th day
Cav(Pharmacokinetic Parameters after Multiple Doses)
Time frame: Evaluation was performed up to the 12th day
AUC0-t,ss(Pharmacokinetic Parameters after Multiple Doses)
Time frame: Evaluation was performed up to the 12th day
AUC0-τ,ss(Pharmacokinetic Parameters after Multiple Doses)
Time frame: Evaluation was performed up to the 12th day
AUC0-∞,ss(Pharmacokinetic Parameters after Multiple Doses)
Time frame: Evaluation was performed up to the 12th day
t1/2(Pharmacokinetic Parameters after Multiple Doses)
Time frame: Evaluation was performed up to the 12th day
CLss(Pharmacokinetic Parameters after Multiple Doses)
Time frame: Evaluation was performed up to the 12th day
Vss(Pharmacokinetic Parameters after Multiple Doses)
Time frame: Evaluation was performed up to the 12th day
Rac(Pharmacokinetic Parameters after Multiple Doses)
Time frame: Evaluation was performed up to the 12th day
DF(Pharmacokinetic Parameters after Multiple Doses)
Time frame: Evaluation was performed up to the 12th day
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 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 HRS-2183 in people with Chinese Healthy Adult Subjects, run by Jiangsu HengRui Medicine 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 17 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 8 Sep 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. 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?
Incidence and severity of any adverse events (time frame: Evaluation was performed up to the seventh day / the 16th day). 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 8 Sep 2026.