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Not yet recruiting NCT06905314

A Single Ascending Dose of HRS-4029 in Healthy Subjects

Phase I Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-4029, Placebo.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HRS-4029 Following a Single Dose in Healthy Subjects

Overview

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

Interventions

  • Drug HRS-4029
    HRS-4029
  • Drug Placebo
    Placebo

Primary outcome measures

  • The incidence and severity of adverse events [Time frame: From ICF signing date to Day15]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • China-Japan Friendship Hospital — Beijing

Identifiers

NCT: NCT06905314 · HRS-4029-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗