A Single Ascending Dose of HRS-4029 in Healthy Subjects

Phase 1

Not yet recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: HRS-4029; Drug: Placebo

• Registration Number: NCT06905314
• Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study Start: 2025-04
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. Age between 18 to 55 years.
2. Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive).
3. Agreed to take effective contraceptive measures during and 3 months after the last dose of the study period.
4. Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).

Exclusion Criteria

1. Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded.
2. Vital signs, physical examination, 12-lead electrocardiogram,or laboratory examination deemed clinically significant by the investigator .
3. Subjects with positive tests for infectious diseases.
4. Female who are pregnant or breastfeeding.
5. Unable to tolerate venipunctures or have a history of fainting needles and blood.
6. Historic abuse of alcoholic beverages
7. Smoke ≥5 cigarettes per day within 3 months prior to the study
8. History of drug abuse.
9. Other reasons that the investigator consider it inappropriate to participate in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	HRS-4029	Drug: HRS-4029 Subject will receive HRS-4029 at dose level 1. Drug: Placebo Subject will receive placebo at dose level 1.
Group A	Placebo	Drug: HRS-4029 Subject will receive HRS-4029 at dose level 1. Drug: Placebo Subject will receive placebo at dose level 1.
Group B	Placebo	Drug: HRS-4029 Subject will receive HRS-4029 at dose level 2. Drug: Placebo Subject will receive placebo at dose level 2.
Group E	Placebo	Drug: HRS-4029 Subject will receive HRS-4029 at dose level 5. Drug: Placebo Subject will receive placebo at dose level 5.
Group B	HRS-4029	Drug: HRS-4029 Subject will receive HRS-4029 at dose level 2. Drug: Placebo Subject will receive placebo at dose level 2.
Group C	Placebo	Drug: HRS-4029 Subject will receive HRS-4029 at dose level 3. Drug: Placebo Subject will receive placebo at dose level 3.
Group C	HRS-4029	Drug: HRS-4029 Subject will receive HRS-4029 at dose level 3. Drug: Placebo Subject will receive placebo at dose level 3.
Group D	HRS-4029	Drug: HRS-4029 Subject will receive HRS-4029 at dose level 4. Drug: Placebo Subject will receive placebo at dose level 4.
Group E	HRS-4029	Drug: HRS-4029 Subject will receive HRS-4029 at dose level 5. Drug: Placebo Subject will receive placebo at dose level 5.
Group D	Placebo	Drug: HRS-4029 Subject will receive HRS-4029 at dose level 4. Drug: Placebo Subject will receive placebo at dose level 4.
Group F	HRS-4029	Drug: HRS-4029 Subject will receive HRS-4029 at dose level 6. Drug: Placebo Subject will receive placebo at dose level 6.
Group F	Placebo	Drug: HRS-4029 Subject will receive HRS-4029 at dose level 6. Drug: Placebo Subject will receive placebo at dose level 6.

Primary Outcome Measures

Name	Time	Method
The incidence and severity of adverse events	From ICF signing date to Day15

Secondary Outcome Measures

Name	Time	Method
Maximum observed concentration of HRS-4029 (Cmax)	0 hour to 48 hour after administration
Area under the serum concentration time curve (AUC) of HRS-4029	0 hour to 48 hour after administration
Time to maximum observed concentration (Tmax) of HRS-4029	0 hour to 48 hour after administration
Number of subjects who developed HRS-4029 antidrug antibodies (ADA)	Baseline to Day15
Half-life (T1/2) of HRS-4029	0 hour to 48 hour after administration
Clearance (CL) of HRS-4029	0 hour to 48 hour after administration
Volume of distribution (Vz) of HRS-4029	0 hour to 48 hour after administration

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China