Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of ARO-033 compared to placebo in adult normal healthy volunteers (NHVs).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARO-033 | Experimental | Participants will receive either a single dose of ARO-033 on Day 1 (single-ascending dose [SAD]) or 2 doses (multiple-ascending dose [MAD]) of ARO-033 administered on Day 1 and Day 29. |
|
| Placebo | Placebo Comparator | Participants will receive either a single dose of placebo on Day 1 (SAD) or 2 doses (MAD) of placebo administered on Day 1 and Day 29. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARO-033 | Drug | ARO-033 will be administered as a subcutaneous (SC) injection per schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Day 225 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of ARO-033 | SAD: Predose (0 hour) up to 48 hours postdose (Day 1 up to Day 3); MAD: Predose (0 hour) up to 18 hours postdose (Days 1 and 29), 24 hours postdose (Days 2 and 30), and 48 hours postdose (Days 3 and 31) | |
| Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUC0-t) of ARO-033 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Contact | 626-304-3400 | ARO033-1001@arrowheadpharma.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo matching to ARO-033 will be administered as SC injection per schedule specified in the arm description. |
|
| SAD: Predose (0 hour) up to 48 hours postdose (Day 1 up to Day 3); MAD: Predose (0 hour) up to 18 hours postdose (Days 1 and 29), 24 hours postdose (Days 2 and 30), and 48 hours postdose (Days 3 and 31) |
| Amount of ARO-033 Excreted in the Urine From Time 0 to 24 Hours After Dosing (Ae) | SAD: Predose (0 hour) up to 8 hours postdose (Day 1), and up to 24 hours postdose (Day 2); MAD: Predose (0 hour) up to 8 hours postdose (Days 1 and 29) |