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COMPLETED
NCT07083362
PHASE1

Safety, Tolerability and Pharmacokinetic Study of HRS-8829

Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

View on ClinicalTrials.gov

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)

Official title: Safety, Tolerability and Pharmacokinetic Studies of Single and Multiple Administrations of HRS-8829 in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

83

Start Date

2025-08-06

Completion Date

2026-01-12

Last Updated

2026-04-28

Healthy Volunteers

Yes

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.

Locations (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China