Healthy VolunteersPhase 1NCT07123376
Pharmacokinetics, Pharmacodynamics Profile and Tolerance of HRS-9231 in Healthy Subjects
A Phase 1 study testing HRS-9231 in people with Healthy Volunteers, run by Shanghai Shengdi Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of HRS-9231 injection in a single dose 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
- Healthy Volunteers
- What is being tested?
- HRS-9231
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2024to 6 Oct 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
- Age between 18 to 45 years.
- Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive).
- Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).
Who cannot join
- Patients with contraindications for magnetic resonance imaging (MRI) examinations.
- During the screening period, those whose 12-lead electrocardiogram examination is judged by clinical doctors as abnormal and of clinical significance will be selected.
- Those with a history of drug abuse, drug use, or positive results in drug abuse screening.
- Unable to tolerate venipunctures or have a history of fainting needles and blood.
- People with various urinary disorders (such as frequent urination, difficulty in urination, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Study Was Conducted to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HRS-9231 Injection in a Single Dose in Healthy Chinese Subjects
To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of HRS-9231 injection in a single dose in healthy subjects
- Conditions
- Healthy Volunteers
- Being tested
- HRS-9231, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9231Drug
HRS-9231 was administered intravenously;
PlaceboDrug
Placebo was administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 8 healthy subjects were to be included Receives: Drug: HRS-9231; Drug: Placebo |
| Group 2 | Experimental | 8 healthy subjects were to be included Receives: Drug: HRS-9231; Drug: Placebo |
| Group 3 | Experimental | 8 healthy subjects were to be included Receives: Drug: HRS-9231; Drug: Placebo |
| Group 4 | Experimental | 8 healthy subjects were to be included Receives: Drug: HRS-9231; Drug: Placebo |
| Group 5 | Experimental | 8 healthy subjects were to be included Receives: Drug: HRS-9231; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, serious adverse events
Measured: From ICF signing date to Day10
Secondary outcomes (3)
Cmax：maximum concentration measured. Blood samples were taken to assess HRS-9231 concentration
Measured: From baseline (1 hour before injection) to 12 hours post-injection
t1/2 = terminal elimination half-life of the compound
Measured: From baseline (1 hour before injection) to 12 hours post-injection
Cl = total clearance
Measured: From baseline (1 hour before injection) to 12 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start5 Jun 2024
- Primary completion6 Oct 2024
- Study completion6 Oct 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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123376
- Sponsor's protocol ID
- HRS-9231-101
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 14 Aug 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 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Study Was Conducted to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HRS-9231 Injection in a Single Dose in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT07123376
- Acronym / sponsor ID
- HRS-9231-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Shengdi Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 6 Oct 2024 (actual)
- Study completion
- 6 Oct 2024 (actual)
- First posted
- 14 Aug 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.
To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of HRS-9231 injection in a single dose in healthy subjects
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: HRS-9231, Drug: Placebo8 healthy subjects were to be included |
| Group 2 | Experimental | Drug: HRS-9231, Drug: Placebo8 healthy subjects were to be included |
| Group 3 | Experimental | Drug: HRS-9231, Drug: Placebo8 healthy subjects were to be included |
| Group 4 | Experimental | Drug: HRS-9231, Drug: Placebo8 healthy subjects were to be included |
| Group 5 | Experimental | Drug: HRS-9231, Drug: Placebo8 healthy subjects were to be included |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 to 45 years.
- Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive).
- Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).
Key exclusion criteria (5 listed)
- Patients with contraindications for magnetic resonance imaging (MRI) examinations.
- During the screening period, those whose 12-lead electrocardiogram examination is judged by clinical doctors as abnormal and of clinical significance will be selected.
- Those with a history of drug abuse, drug use, or positive results in drug abuse screening.
- Unable to tolerate venipunctures or have a history of fainting needles and blood.
- People with various urinary disorders (such as frequent urination, difficulty in urination, etc.)
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-9231HRS-9231 was administered intravenously; | Drug | Group 1, Group 2, Group 3, Group 4, Group 5 |
| PlaceboPlacebo was administered intravenously. | Drug | Group 1, Group 2, Group 3, Group 4, Group 5 |
Primary outcome
Adverse events, serious adverse events
Time frame: From ICF signing date to Day10
3 secondary outcomes
Cmax：maximum concentration measured. Blood samples were taken to assess HRS-9231 concentration
Time frame: From baseline (1 hour before injection) to 12 hours post-injection
t1/2 = terminal elimination half-life of the compound
Time frame: From baseline (1 hour before injection) to 12 hours post-injection
Cl = total clearance
Time frame: From baseline (1 hour before injection) to 12 hours post-injection
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 14 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
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 HRS-9231 in people with Healthy Volunteers, run by Shanghai Shengdi 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 3 inclusion and 5 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 14 Aug 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?
Adverse events, serious adverse events (time frame: From ICF signing date to Day10). 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 14 Aug 2025.