Safety and Tolerance of Increased Doses of HRS-1780 Tablets in Healthy Subjects

NCT05638126 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-10-25

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-1780 in healthy subjects, and to evaluate the food effect on PK of HRS-1780.

Conditions

Interventions

DRUG

HRS-1780 table or placebo

HRS-1780 table or placebo single dose

DRUG

HRS-1780 table or placebo

HRS-1780 table or placebo single dose with food effect

DRUG

HRS-1780 table or placebo

HRS-1780 table or placebo multiple dose

Sponsors & Collaborators

  • Shandong Suncadia Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-02
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Entities

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 NCT05638126 on ClinicalTrials.gov