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NCT Number: NCT06905314

A Single Ascending Dose of HRS-4029 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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location contact

Jintong Li

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HRS-4029

Drug

HRS-4029

Placebo

Drug

Placebo

Primary outcomes

  1. The incidence and severity of adverse events

    Time frame: From ICF signing date to Day15

Secondary outcomes

  1. Maximum observed concentration of HRS-4029 (Cmax)

    Time frame: 0 hour to 48 hour after administration

  2. Area under the serum concentration time curve (AUC) of HRS-4029

    Time frame: 0 hour to 48 hour after administration

  3. Time to maximum observed concentration (Tmax) of HRS-4029

    Time frame: 0 hour to 48 hour after administration

  4. Half-life (T1/2) of HRS-4029

    Time frame: 0 hour to 48 hour after administration

  5. Clearance (CL) of HRS-4029

    Time frame: 0 hour to 48 hour after administration

  6. Volume of distribution (Vz) of HRS-4029

    Time frame: 0 hour to 48 hour after administration

  7. Number of subjects who developed HRS-4029 antidrug antibodies (ADA)

    Time frame: Baseline to Day15

Study contacts

Contact information is provided by the study sponsor or research team.

Yuanyuan Huang

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2025
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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