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

S

Shandong Suncadia Medicine

Status and phase

Enrolling
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

106 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • History of persistent tachyarrhythmia and syncope;
  • A history of stomach or bowel surgery or excision (e.g. appendectomy, hernia repair, and/or cholecystectomy);
  • 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

106 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

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Central trial contact

Xiaoyi Sun; Sheng Qi

Data sourced from clinicaltrials.gov

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