What is ARO-033 studying for healthy adults?

ARO-033 is being studied to understand its safety, how well it is tolerated, and how it affects the body when given as single or multiple doses. Researchers want to learn how the drug behaves in healthy adults, which helps guide future development. The study is sponsored by Arrowhead Pharmaceuticals.

Who may be eligible for this healthy adult clinical trial?

Adults aged 18 to 65 who are healthy and not pregnant or breastfeeding may be eligible. Participants should have a body mass index between 18.0 and 35.0 kg/m² and no major recent surgery. People with certain infections, uncontrolled high blood pressure, or immune system problems are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this healthy adult clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years - 65Years

All Genders

Healthy Volunteers

ID07662096

Study of Safety, Tolerability, and Body Effects of Single and Multiple Doses of ARO-033 Compared to Placebo in Healthy Adults Aged 18 to 65

Led by Arrowhead Pharmaceuticals · Updated on 2026-07-22

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and body effects of single and multiple doses of ARO-033 compared to placebo in healthy adult volunteers aged 18 to 65. This Phase 1 study focuses on measuring how the body processes the drug, including pharmacokinetics and pharmacodynamics, to understand its potential impacts. Participants are randomly assigned to receive either a single subcutaneous injection of ARO-033 or placebo on Day 1 single-ascending dose, or two doses on Day 1 and Day 29 multiple-ascending dose. The study includes a parallel design with quadruple masking to compare these groups effectively while monitoring safety and drug behavior. During the study, participants undergo regular assessments for treatment-emergent adverse events up to Day 225. Blood and urine samples will be collected at specified times to measure drug concentrations and excretion. Overall participation lasts through the primary completion date, with close monitoring of safety, tolerability, and drug effects over several months.

CONDITIONS

Brief Title

A First-In-Human Study of ARO-033 in Adult Participants

Who Can Participate

Age: 18Years - 65Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 65 years
Not pregnant, not breastfeeding, and no plans for pregnancy during the study and for at least 90 days after
Body mass index (BMI) between 18.0 and 35.0 kg/m²
No abnormal clinical findings that could affect safety or study results

You will not qualify if you...

HIV infection (seropositive)
Positive for hepatitis B surface antigen or active hepatitis C infection
Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥95 mmHg)
Significant immunocompromising conditions or ongoing immunosuppressive treatment
Major surgery within 90 days before screening
Use of investigational agent or device within 30 days or 5 half-lives before dosing
Any medical condition or lab abnormality that could affect safety or study results

Research Team

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Study of Safety, Tolerability, and Body Effects of Single and Multiple Doses of ARO-033 Compared to Placebo in Healthy Adults Aged 18 to 65

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria