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

NCT ID: NCT06519981

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-21

Study Completion Date

2024-11-27

Brief Summary

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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

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Conditions

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MRI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Healthy participants are planned to be enrolled in a single ascending dose study. For each cohort, participants will randomly receive HRS-9231/Placebo injection by an intravenous (IV) administration
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HRS-9231 or matching placebo Dose level 1

Dose level 1

Group Type EXPERIMENTAL

HRS-9231or matching placebo

Intervention Type DRUG

HRS-9231 injection or matching placebo will be administered through IV injection.

HRS-9231 or matching placebo Dose level 2

Group Type EXPERIMENTAL

HRS-9231or matching placebo

Intervention Type DRUG

HRS-9231 injection or matching placebo will be administered through IV injection.

Interventions

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HRS-9231or matching placebo

HRS-9231 injection or matching placebo will be administered through IV injection.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Atridia Pty Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Linear Clinical research

Perth, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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HRS-9231-102

Identifier Type: -

Identifier Source: org_study_id