NCT06905314

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 25, 2025

Last Update Submit

March 25, 2025

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • The incidence and severity of adverse events

    From ICF signing date to Day15

Secondary Outcomes (7)

  • Maximum observed concentration of HRS-4029 (Cmax)

    0 hour to 48 hour after administration

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

    0 hour to 48 hour after administration

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

    0 hour to 48 hour after administration

  • Half-life (T1/2) of HRS-4029

    0 hour to 48 hour after administration

  • Clearance (CL) of HRS-4029

    0 hour to 48 hour after administration

  • +2 more secondary outcomes

Study Arms (6)

Group A

EXPERIMENTAL

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

Drug: HRS-4029Drug: Placebo

Group B

EXPERIMENTAL

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

Drug: HRS-4029Drug: Placebo

Group C

EXPERIMENTAL

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

Drug: HRS-4029Drug: Placebo

Group D

EXPERIMENTAL

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

Drug: HRS-4029Drug: Placebo

Group E

EXPERIMENTAL

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

Drug: HRS-4029Drug: Placebo

Group F

EXPERIMENTAL

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

Drug: HRS-4029Drug: Placebo

Interventions

HRS-4029DRUG

HRS-4029

Group AGroup BGroup CGroup DGroup EGroup F
PlaceboDRUG

Placebo

Group AGroup BGroup CGroup DGroup EGroup F

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Yuanyuan Huang

CONTACT

0518-82342973yuanyuan.huang@hengrui.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 1, 2025

Study Start

April 1, 2025

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Locations

CN(1)