Status:
COMPLETED
Phase 1 Study of HRS-9231 Safety and Pharmacokinetics in Healthy Caucasians
Lead Sponsor:
Atridia Pty Ltd.
Conditions:
MRI
Eligibility:
All Genders
18-45 years
Phase:
EARLY_PHASE1
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
August 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06519981
Start Date
August 21 2024
End Date
November 27 2024
Last Update
December 6 2024
Active Locations (1)
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1
Linear Clinical research
Perth, Western Australia, Australia