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
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