A Single Ascending Dose of HRS-4029 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2025-12-31

Brief Summary

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The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-4029 following a single intravenous dose administration in healthy subjects.

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Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

Drug: HRS-4029 Subject will receive HRS-4029 at dose level 1. Drug: Placebo Subject will receive placebo at dose level 1.

Group Type EXPERIMENTAL

HRS-4029

Intervention Type DRUG

HRS-4029

Placebo

Intervention Type DRUG

Placebo

Group B

Drug: HRS-4029 Subject will receive HRS-4029 at dose level 2. Drug: Placebo Subject will receive placebo at dose level 2.

Group Type EXPERIMENTAL

HRS-4029

Intervention Type DRUG

HRS-4029

Placebo

Intervention Type DRUG

Placebo

Group C

Drug: HRS-4029 Subject will receive HRS-4029 at dose level 3. Drug: Placebo Subject will receive placebo at dose level 3.

Group Type EXPERIMENTAL

HRS-4029

Intervention Type DRUG

HRS-4029

Placebo

Intervention Type DRUG

Placebo

Group D

Drug: HRS-4029 Subject will receive HRS-4029 at dose level 4. Drug: Placebo Subject will receive placebo at dose level 4.

Group Type EXPERIMENTAL

HRS-4029

Intervention Type DRUG

HRS-4029

Placebo

Intervention Type DRUG

Placebo

Group E

Drug: HRS-4029 Subject will receive HRS-4029 at dose level 5. Drug: Placebo Subject will receive placebo at dose level 5.

Group Type EXPERIMENTAL

HRS-4029

Intervention Type DRUG

HRS-4029

Placebo

Intervention Type DRUG

Placebo

Group F

Drug: HRS-4029 Subject will receive HRS-4029 at dose level 6. Drug: Placebo Subject will receive placebo at dose level 6.

Group Type EXPERIMENTAL

HRS-4029

Intervention Type DRUG

HRS-4029

Placebo

Intervention Type DRUG

Placebo

Interventions

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HRS-4029

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes