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

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

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.

Study Overview

• Status: Completed
• Conditions: MRI
• Intervention / Treatment: Drug: HRS-9231or matching placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Perth, Western Australia, Australia
      • Linear Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-9231 or matching placebo Dose level 1; Dose level 1	Drug: HRS-9231or matching placebo; HRS-9231 injection or matching placebo will be administered through IV injection.
Experimental: HRS-9231 or matching placebo Dose level 2	Drug: HRS-9231or matching placebo; HRS-9231 injection or matching placebo will be administered through IV injection.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Atridia Pty Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Actual): September 29, 2024
• Study Completion (Actual): November 27, 2024

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HRS-9231-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No