Acute Ischemic StrokePhase 1NCT06905314
A Single Ascending Dose of HRS-4029 in Healthy Subjects
A Phase 1 study testing HRS-4029 in people with Acute Ischemic Stroke, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-4029 following a single intravenous dose administration in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- HRS-4029
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- Apr 2025to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Age between 18 to 55 years.
- Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive).
- Agreed to take effective contraceptive measures during and 3 months after the last dose of the study period.
- 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
- Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded.
- Vital signs, physical examination, 12-lead electrocardiogram,or laboratory examination deemed clinically significant by the investigator .
- Subjects with positive tests for infectious diseases.
- Female who are pregnant or breastfeeding.
- Unable to tolerate venipunctures or have a history of fainting needles and blood.
- Historic abuse of alcoholic beverages
Show all 9Show fewer
- Smoke ≥5 cigarettes per day within 3 months prior to the study
- History of drug abuse.
- Other reasons that the investigator consider it inappropriate to participate in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Jintong Li
About this study
Official title: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HRS-4029 Following a Single Dose in Healthy Subjects
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-4029 following a single intravenous dose administration in healthy subjects.
- Conditions
- Acute Ischemic Stroke
- Being tested
- HRS-4029, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4029Drug
HRS-4029
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Drug: HRS-4029 Subject will receive HRS-4029 at dose level 1. Drug: Placebo Subject will receive placebo at dose level 1. Receives: Drug: HRS-4029; Drug: Placebo |
| Group B | Experimental | Drug: HRS-4029 Subject will receive HRS-4029 at dose level 2. Drug: Placebo Subject will receive placebo at dose level 2. Receives: Drug: HRS-4029; Drug: Placebo |
| Group C | Experimental | Drug: HRS-4029 Subject will receive HRS-4029 at dose level 3. Drug: Placebo Subject will receive placebo at dose level 3. Receives: Drug: HRS-4029; Drug: Placebo |
| Group D | Experimental | Drug: HRS-4029 Subject will receive HRS-4029 at dose level 4. Drug: Placebo Subject will receive placebo at dose level 4. Receives: Drug: HRS-4029; Drug: Placebo |
| Group E | Experimental | Drug: HRS-4029 Subject will receive HRS-4029 at dose level 5. Drug: Placebo Subject will receive placebo at dose level 5. Receives: Drug: HRS-4029; Drug: Placebo |
| Group F | Experimental | Drug: HRS-4029 Subject will receive HRS-4029 at dose level 6. Drug: Placebo Subject will receive placebo at dose level 6. Receives: Drug: HRS-4029; Drug: 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
Measured: From ICF signing date to Day15
Secondary outcomes (7)
Maximum observed concentration of HRS-4029 (Cmax)
Measured: 0 hour to 48 hour after administration
Area under the serum concentration time curve (AUC) of HRS-4029
Measured: 0 hour to 48 hour after administration
Time to maximum observed concentration (Tmax) of HRS-4029
Measured: 0 hour to 48 hour after administration
Half-life (T1/2) of HRS-4029
Measured: 0 hour to 48 hour after administration
Clearance (CL) of HRS-4029
Measured: 0 hour to 48 hour after administration
Volume of distribution (Vz) of HRS-4029
Measured: 0 hour to 48 hour after administration
Number of subjects who developed HRS-4029 antidrug antibodies (ADA)
Measured: Baseline to Day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Suncadia Pharmaceuticals 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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905314
- Sponsor's protocol ID
- HRS-4029-101
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 1 Apr 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HRS-4029 Following a Single Dose in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06905314
- Acronym / sponsor ID
- HRS-4029-101
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Apr 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 and pharmacokinetics of HRS-4029 following a single intravenous dose administration 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
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: HRS-4029, Drug: PlaceboDrug: HRS-4029 Subject will receive HRS-4029 at dose level 1. Drug: Placebo Subject will receive placebo at dose level 1. |
| Group B | Experimental | Drug: HRS-4029, Drug: PlaceboDrug: HRS-4029 Subject will receive HRS-4029 at dose level 2. Drug: Placebo Subject will receive placebo at dose level 2. |
| Group C | Experimental | Drug: HRS-4029, Drug: PlaceboDrug: HRS-4029 Subject will receive HRS-4029 at dose level 3. Drug: Placebo Subject will receive placebo at dose level 3. |
| Group D | Experimental | Drug: HRS-4029, Drug: PlaceboDrug: HRS-4029 Subject will receive HRS-4029 at dose level 4. Drug: Placebo Subject will receive placebo at dose level 4. |
| Group E | Experimental | Drug: HRS-4029, Drug: PlaceboDrug: HRS-4029 Subject will receive HRS-4029 at dose level 5. Drug: Placebo Subject will receive placebo at dose level 5. |
| Group F | Experimental | Drug: HRS-4029, Drug: PlaceboDrug: HRS-4029 Subject will receive HRS-4029 at dose level 6. Drug: Placebo Subject will receive placebo at dose level 6. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 to 55 years.
- Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive).
- Agreed to take effective contraceptive measures during and 3 months after the last dose of the study period.
- 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 (9 listed)
- Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded.
- Vital signs, physical examination, 12-lead electrocardiogram,or laboratory examination deemed clinically significant by the investigator .
- Subjects with positive tests for infectious diseases.
- Female who are pregnant or breastfeeding.
- Unable to tolerate venipunctures or have a history of fainting needles and blood.
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-4029HRS-4029 | Drug | Group A, Group B, Group C, Group D, Group E, Group F |
| PlaceboPlacebo | Drug | Group A, Group B, Group C, Group D, Group E, Group F |
Primary outcome
The incidence and severity of adverse events
Time frame: From ICF signing date to Day15
7 secondary outcomes
Maximum observed concentration of HRS-4029 (Cmax)
Time frame: 0 hour to 48 hour after administration
Area under the serum concentration time curve (AUC) of HRS-4029
Time frame: 0 hour to 48 hour after administration
Time to maximum observed concentration (Tmax) of HRS-4029
Time frame: 0 hour to 48 hour after administration
Half-life (T1/2) of HRS-4029
Time frame: 0 hour to 48 hour after administration
Clearance (CL) of HRS-4029
Time frame: 0 hour to 48 hour after administration
Volume of distribution (Vz) of HRS-4029
Time frame: 0 hour to 48 hour after administration
Number of subjects who developed HRS-4029 antidrug antibodies (ADA)
Time frame: Baseline to Day15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- 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.
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-4029 in people with Acute Ischemic Stroke, run by Beijing Suncadia Pharmaceuticals 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 9 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: opening soon, as of the sponsor's last update on 1 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuanyuan Huang (0518-82342973, yuanyuan.huang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events (time frame: From ICF signing date to Day15). 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 1 Apr 2025.