A Single Ascending Dose of HRS-4029 in Healthy Subjects

Beijing Suncadia Pharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Acute Ischemic Stroke

Treatments: Drug: Placebo; Drug: HRS-4029

Study type: Interventional

Funder types: Industry

Identifiers

NCT06905314

HRS-4029-101

Details and patient eligibility

About

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

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 6 patient groups

Group A

Experimental group

Description:

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

Treatment:

Drug: HRS-4029

Drug: Placebo

Group B

Experimental group

Description:

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

Treatment:

Drug: HRS-4029

Drug: Placebo

Group C

Experimental group

Description:

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

Treatment:

Drug: HRS-4029

Drug: Placebo

Group D

Experimental group

Description:

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

Treatment:

Drug: HRS-4029

Drug: Placebo

Group E

Experimental group

Description:

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

Treatment:

Drug: HRS-4029

Drug: Placebo

Group F

Experimental group

Description:

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

Treatment:

Drug: HRS-4029

Drug: Placebo