Safety, Tolerability and Pharmacokinetic Study of HRS-8829
NCT07083362 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83
Last updated 2026-04-28
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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