ClinicalTrials.Veeva

Menu

A Trial of HRS-1893 in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy

S

Shandong Suncadia Medicine

Status and phase

Completed
Phase 1

Conditions

Obstructive Hypertrophic Cardiomyopathy

Treatments

Drug: Placebo
Drug: HRS-1893

Study type

Interventional

Funder types

Industry

Identifiers

NCT05879523
HRS-1893-101

Details and patient eligibility

About

The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-1893 in healthy volunteers and patients with obstructive hypertrophic cardiomyopathy

Enrollment

76 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF)
  2. Male or female aged 18-55(adult healthy volunteers)or 18-85 (oHCM patients).
  3. Body mass index (BMI) between 19 and 28 kg/m2.
  4. Normal Electrocardiogram (ECG)

Exclusion criteria

  1. History of persistent tachyarrhythmia and syncope;
  2. A history of stomach or bowel surgery or excision (e.g. appendectomy, hernia repair, and/or cholecystectomy);
  3. Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

76 participants in 3 patient groups, including a placebo group

HRS-1893 for single ascending dose (SAD) cohorts
Experimental group
Description:
Subjects will be assigned to one of 6 planned dose cohorts and receive single dose of HRS-1893
Treatment:
Drug: HRS-1893
Placebo comparator for SAD cohorts
Placebo Comparator group
Description:
Subjects will be assigned to one of 6 planned dose cohorts and receive single dose of placebo comparator
Treatment:
Drug: Placebo
HRS-1893 for multiple ascending dose (MAD) cohorts
Experimental group
Description:
Subjects will receive multiple doses of 2-4 planned dose cohorts and receive single dose of placebo comparator for MAD cohorts
Treatment:
Drug: HRS-1893

Trial contacts and locations

1

Loading...

Central trial contact

Sheng Qi; Xiaoyi Sun

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems