Ireland
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Starting soon Phase 1

A Single Ascending Dose of HRS-4029 in Healthy Subjects

NCT06905314 · tracked via the Priya Life Science Japan tracker
Phase
Phase 1
Started
2025-04
Last updated
2025-04-01

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

HRS-4029 →Placebo

HRS-4029: HRS-4029

Placebo: Placebo

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • The incidence and severity of adverse events — From ICF signing date to Day15

Trial sites (1)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06905314 on ClinicalTrials.gov ↗ ← All trials in Japan