MRI
Conditions
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.
Interventions
DRUGHRS-9231or matching placebo
HRS-9231 injection or matching placebo will be administered through IV injection.
Sponsors
Atridia Pty Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Day 8 | Number of patients with adverse events (AEs) and serious adverse event (SAE) |
| Vital signs | Day 8 | Number of patients with clinically significant change from baseline in vital signs values |
| Physical examination | Day 8 | Number of patients with clinically significant change in physical examination |
| Laboratory | Day 8 | Number of patients with clinically significant change from baseline in laboratory examination |
| ECG | Day 8 | Number of patients with clinically significant change from baseline in 12-ECG values |
| Injection site reaction | Day 8 | Number of patients with injection site reaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics PK Vz | Day 1 | Plasma Pharmacokinetics: Vz |
| Pharmacokinetics PK MRTlast | Day 1 | Plasma Pharmacokinetics: MRTlast |
| Pharmacokinetics PK MRTinf | Day 1 | Plasma Pharmacokinetics: MRTinf |
| Pharmacokinetics PK Cmax | Day 1 | Plasma Pharmacokinetics: Cmax |
| Pharmacokinetics PK ur | Day 3 | Urine Pharmacokinetics: ur |
| Pharmacokinetics PK %Ae | Day 3 | Urine Pharmacokinetics: %Ae |
| Pharmacokinetics PK CLr | Day 3 | Urine Pharmacokinetics: CLr |
| Pharmacokinetics PK Ae | Day 3 | Urine Pharmacokinetics: Ae |
| Pharmacokinetics PK AUC0-t | Day 1 | Plasma Pharmacokinetics: AUC0-t |
| Pharmacokinetics PK AUC0-inf | Day 1 | Plasma Pharmacokinetics: AUC0-inf |
| Pharmacokinetics PK Tmax | Day 1 | Plasma Pharmacokinetics: Tmax |
| Pharmacokinetics PK t1/2 | Day 1 | Plasma Pharmacokinetics: t1/2 |
| Pharmacokinetics PK CL | Day 1 | Plasma Pharmacokinetics: CL |
Countries
Australia
Outcome results
None listed