Phase 1 Study of HRS-9231 Safety and Pharmacokinetics in Healthy Caucasians

Early Phase 1

Completed

• Conditions: MRI
• Interventions: Drug: HRS-9231or matching placebo

• Registration Number: NCT06519981
• Lead Sponsor: Atridia Pty Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-25
• Study Start: 2024-08-21
• Primary Completion: 2024-09-29
• Status Verified: 2024-10
• Study Completion: 2024-11-27
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRS-9231 or matching placebo Dose level 1	HRS-9231or matching placebo	Dose level 1
HRS-9231 or matching placebo Dose level 2	HRS-9231or matching placebo	-

Primary Outcome Measures

Name	Time	Method
Physical examination	Day 8	Number of patients with clinically significant change in physical examination
ECG	Day 8	Number of patients with clinically significant change from baseline in 12-ECG values
Injection site reaction	Day 8	Number of patients with injection site reaction
Adverse events	Day 8	Number of patients with adverse events (AEs) and serious adverse event (SAE)
Vital signs	Day 8	Number of patients with clinically significant change from baseline in vital signs values
Laboratory	Day 8	Number of patients with clinically significant change from baseline in laboratory examination

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics PK MRTlast	Day 1	Plasma Pharmacokinetics: MRTlast
Pharmacokinetics PK t1/2	Day 1	Plasma Pharmacokinetics: t1/2
Pharmacokinetics PK %Ae	Day 3	Urine Pharmacokinetics: %Ae
Pharmacokinetics PK ur	Day 3	Urine Pharmacokinetics: ur
Pharmacokinetics PK Cmax	Day 1	Plasma Pharmacokinetics: Cmax
Pharmacokinetics PK AUC0-t	Day 1	Plasma Pharmacokinetics: AUC0-t
Pharmacokinetics PK AUC0-inf	Day 1	Plasma Pharmacokinetics: AUC0-inf
Pharmacokinetics PK Tmax	Day 1	Plasma Pharmacokinetics: Tmax
Pharmacokinetics PK CL	Day 1	Plasma Pharmacokinetics: CL
Pharmacokinetics PK Vz	Day 1	Plasma Pharmacokinetics: Vz
Pharmacokinetics PK MRTinf	Day 1	Plasma Pharmacokinetics: MRTinf
Pharmacokinetics PK Ae	Day 3	Urine Pharmacokinetics: Ae
Pharmacokinetics PK CLr	Day 3	Urine Pharmacokinetics: CLr

Trial Locations

Locations (1)

Linear Clinical research; 🇦🇺 Perth, Western Australia, Australia