Safety, Tolerability and Pharmacokinetic Study of HRS-8829

NCT07083362 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2026-04-28

No results posted yet for this study

Summary

This study adopted a single-center, randomized, double-blind, placebo-controlled, dose-escalation design and was divided into three parts: single-dose dose-escalation (SAD) 、 multiple-dose dose-escalation (MAD)、drug-drug interaction(DDI)

Conditions

  • Acute Ischemia Stroke

Interventions

DRUG

HRS-8829;Placebo

Subject will receive HRS-8829 at dose level 1. Subject will receive placebo at dose level 1.

DRUG

HRS-8829;Placebo

Subject will receive HRS-8829 at dose level 2. Subject will receive placebo at dose level 2.

DRUG

HRS-8829;Placebo

Subject will receive HRS-8829 at dose level 3. Subject will receive placebo at dose level 3.

DRUG

HRS-8829;Placebo

Subject will receive HRS-8829 at dose level 4. Subject will receive placebo at dose level 4.

DRUG

HRS-8829;Edaravone injection

Subject will receive HRS-8829 at dose level 2. Subject will receive edaravone injection at dose level 5.

Sponsors & Collaborators

  • Beijing Suncadia Pharmaceuticals Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-06
Primary Completion
2026-01-12
Completion
2026-01-12

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07083362 on ClinicalTrials.gov