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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07033455




Registration number
NCT07033455
Ethics application status
Date submitted
20/05/2025
Date registered
24/06/2025
Date last updated
29/06/2025

Titles & IDs
Public title
A Trial of HRS-1893 in Healthy Volunteers
Scientific title
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of HRS-1893 in Healthy Participants
Secondary ID [1] 0 0
HRS-1893-105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertrophic Cardiomyopathy 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HRS-1893

Experimental: HRS-1893 Dose level 1 - Single oral low dose of HRS-1893 (dose level 1)

Experimental: HRS-1893 Dose level 2 - Single oral high dose of HRS-1893 (dose level 2)


Treatment: Drugs: HRS-1893
Single dose of HRS-1893 orally administered
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PK profile of HRS-1893 after a single oral (PO) administration
Timepoint [1] 0 0
Day 8
Primary outcome [2] 0 0
PK profile of HRS-1893 after a single oral (PO) administration
Timepoint [2] 0 0
Day 8
Primary outcome [3] 0 0
PK profile of HRS-1893 after a single oral (PO) administration
Timepoint [3] 0 0
Day 8
Primary outcome [4] 0 0
PK profile of HRS-1893 after a single oral (PO) administration
Timepoint [4] 0 0
Day 8
Primary outcome [5] 0 0
PK profile of HRS-1893 after a single oral (PO) administration
Timepoint [5] 0 0
Day 8
Primary outcome [6] 0 0
PK profile of HRS-1893 after a single oral (PO) administration
Timepoint [6] 0 0
Day 8
Primary outcome [7] 0 0
PK profile of HRS-1893 after a single oral (PO) administration
Timepoint [7] 0 0
Day 8
Primary outcome [8] 0 0
Cumulative amount of drug excreted in urine of HRS-1893 after a single oral administration
Timepoint [8] 0 0
Day 8
Primary outcome [9] 0 0
Cumulative percentage of dose recovered in urine of HRS-1893 after a single oral administration:
Timepoint [9] 0 0
Day 8
Primary outcome [10] 0 0
Renal clearance of HRS-1893 after a single oral administration
Timepoint [10] 0 0
Day 8
Secondary outcome [1] 0 0
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Timepoint [1] 0 0
Day 8

Eligibility
Key inclusion criteria
1. Healthy white participants;
2. Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
3. Male aged between 18 to 55 years of age (inclusive)
4. Women with body weight = 45.0 kg, men with body weight = 50.0 kg, body mass index (BMI) between 19.0 and 30.0 kg/m2 (inclusive) at screening.
5. Negative pregnancy test for women of childbearing potential (WOCBP) at baseline. Men and WOCBP must agree to take highly effective contraceptive methods
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History or evidence of clinically significant disorders
2. History of cardiomyopathy and/or unexplained heart failure
3. Individuals with a history of drug allergies, specific allergies
4. Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathy You
Address 0 0
Country 0 0
Phone 0 0
+61 02 9299 0433
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07033455