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

Atridia

Status and phase: Completed; Early Phase 1

Conditions: MRI

Treatments: Drug: HRS-9231or matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06519981

HRS-9231-102

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

HRS-9231 or matching placebo Dose level 1

Experimental group

Description:

Dose level 1

Treatment:

Drug: HRS-9231or matching placebo

HRS-9231 or matching placebo Dose level 2

Experimental group

Treatment:

Drug: HRS-9231or matching placebo