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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-9231 or matching placebo Dose level 1 | Experimental | Dose level 1 |
|
| HRS-9231 or matching placebo Dose level 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-9231or matching placebo | Drug | HRS-9231 injection or matching placebo will be administered through IV injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics PK Cmax | Plasma Pharmacokinetics: Cmax | Day 1 |
| Pharmacokinetics PK AUC0-t | Plasma Pharmacokinetics: AUC0-t | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical research | Perth | Western Australia | Australia |
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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
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| Pharmacokinetics PK AUC0-inf | Plasma Pharmacokinetics: AUC0-inf | Day 1 |
| Pharmacokinetics PK Tmax | Plasma Pharmacokinetics: Tmax | Day 1 |
| Pharmacokinetics PK t1/2 | Plasma Pharmacokinetics: t1/2 | Day 1 |
| Pharmacokinetics PK CL | Plasma Pharmacokinetics: CL | Day 1 |
| Pharmacokinetics PK Vz | Plasma Pharmacokinetics: Vz | Day 1 |
| Pharmacokinetics PK MRTlast | Plasma Pharmacokinetics: MRTlast | Day 1 |
| Pharmacokinetics PK MRTinf | Plasma Pharmacokinetics: MRTinf | Day 1 |
| Pharmacokinetics PK Ae | Urine Pharmacokinetics: Ae | Day 3 |
| Pharmacokinetics PK ur | Urine Pharmacokinetics: ur | Day 3 |
| Pharmacokinetics PK %Ae | Urine Pharmacokinetics: %Ae | Day 3 |
| Pharmacokinetics PK CLr | Urine Pharmacokinetics: CLr | Day 3 |