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

NCT06519981 | Completed Early Phase 1

• 1 other identifier: HRS-9231-102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

MRI

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (13)

• Pharmacokinetics PK Cmax

  Day 1

• Pharmacokinetics PK AUC0-t

  Day 1

• Pharmacokinetics PK AUC0-inf

  Day 1

• Pharmacokinetics PK Tmax

  Day 1

• Pharmacokinetics PK t1/2

  Day 1

Study Arms (2)

HRS-9231 or matching placebo Dose level 1

EXPERIMENTAL

Dose level 1

Drug: HRS-9231or matching placebo

HRS-9231 or matching placebo Dose level 2

EXPERIMENTAL

Drug: HRS-9231or matching placebo

Interventions

HRS-9231or matching placebo DRUG

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

HRS-9231 or matching placebo Dose level 1; HRS-9231 or matching placebo Dose level 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Caucasian participants;
• Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
• Male or female aged between 18 to 45 years of age (inclusive) at the date of signed consent form.
• 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

You may not qualify if:

• History or evidence of clinically significant disorders
• Individuals with a history of drug allergies, specific allergies
• 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.
• Any other circumstances (e.g., not suitable for venous access) or laboratory
• 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.

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (1)

Linear Clinical research

Perth, Western Australia, Australia

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 25, 2024
• Study Start: August 21, 2024
• Primary Completion: September 29, 2024
• Study Completion: November 27, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-10

Locations

AU (1)