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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06519981




Registration number
NCT06519981
Ethics application status
Date submitted
2/07/2024
Date registered
25/07/2024
Date last updated
16/10/2024

Titles & IDs
Public title
Phase 1 Study of HRS-9231 Safety and Pharmacokinetics in Healthy Caucasians
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-9231 in Healthy Caucasian Participants
Secondary ID [1] 0 0
HRS-9231-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
MRI 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HRS-9231or matching placebo

Experimental: HRS-9231 or matching placebo Dose level 1 - Dose level 1

Experimental: HRS-9231 or matching placebo Dose level 2 -


Treatment: Drugs: HRS-9231or matching placebo
HRS-9231 injection or matching placebo will be administered through IV injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
Day 8
Primary outcome [2] 0 0
Vital signs
Timepoint [2] 0 0
Day 8
Primary outcome [3] 0 0
Physical examination
Timepoint [3] 0 0
Day 8
Primary outcome [4] 0 0
Laboratory
Timepoint [4] 0 0
Day 8
Primary outcome [5] 0 0
ECG
Timepoint [5] 0 0
Day 8
Primary outcome [6] 0 0
Injection site reaction
Timepoint [6] 0 0
Day 8
Secondary outcome [1] 0 0
Pharmacokinetics PK Cmax
Timepoint [1] 0 0
Day 1
Secondary outcome [2] 0 0
Pharmacokinetics PK AUC0-t
Timepoint [2] 0 0
Day 1
Secondary outcome [3] 0 0
Pharmacokinetics PK AUC0-inf
Timepoint [3] 0 0
Day 1
Secondary outcome [4] 0 0
Pharmacokinetics PK Tmax
Timepoint [4] 0 0
Day 1
Secondary outcome [5] 0 0
Pharmacokinetics PK t1/2
Timepoint [5] 0 0
Day 1
Secondary outcome [6] 0 0
Pharmacokinetics PK CL
Timepoint [6] 0 0
Day 1
Secondary outcome [7] 0 0
Pharmacokinetics PK Vz
Timepoint [7] 0 0
Day 1
Secondary outcome [8] 0 0
Pharmacokinetics PK MRTlast
Timepoint [8] 0 0
Day 1
Secondary outcome [9] 0 0
Pharmacokinetics PK MRTinf
Timepoint [9] 0 0
Day 1
Secondary outcome [10] 0 0
Pharmacokinetics PK Ae
Timepoint [10] 0 0
Day 3
Secondary outcome [11] 0 0
Pharmacokinetics PK ur
Timepoint [11] 0 0
Day 3
Secondary outcome [12] 0 0
Pharmacokinetics PK %Ae
Timepoint [12] 0 0
Day 3
Secondary outcome [13] 0 0
Pharmacokinetics PK CLr
Timepoint [13] 0 0
Day 3

Eligibility
Key inclusion criteria
1. Healthy Caucasian participants;
2. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
3. Male or female aged between 18 to 45 years of age (inclusive) at the date of signed consent form.
4. Women with body weight of = 45.0 kg, men with body weight = 50.0 kg, body mass Index (BMI) between 18.0 and 32.0 kg/m2
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History or evidence of clinically significant disorders
2. Individuals with a history of drug allergies, specific allergies
3. Severe infections, injuries, or major surgeries as determined by the investigator within 3 months prior to dosing, or plan to do surgeries during the study.
4. Any other circumstances (e.g., not suitable for venous access) or laboratory
5. 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/10/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical research - Perth
Recruitment postcode(s) [1] 0 0
- Perth

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase 1, randomized, double-blind, placebo-controlled study. The objective of this study is to evaluate the safety, tolerability, and PK profile of HRS-9231 injection following a single dose in healthy Caucasian participants.
Trial website
https://clinicaltrials.gov/study/NCT06519981
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 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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06519981