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
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
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- 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.
- 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