NCT07662096 A First-In-Human Study of ARO-033 in Adult Participants
| NCT ID | NCT07662096 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Arrowhead Pharmaceuticals |
| Condition | Healthy Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-06-25 |
| Primary Completion | 2027-07-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2026-06-25 with a primary completion date of 2027-07-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Key Inclusion Criteria: * Adults who are not pregnant, not breastfeeding, and do not plan to become pregnant (or impregnate their partners) during the study and for at least 90 days following the end of the study. * Body mass index (BMI) between 18.0 and 35.0 kilograms (kg)/square meter (m\^2), inclusive. * No abnormal finding of clinical relevance at the Screening evaluation that in the opinion of the Investigator could adversely impact participant's safety during the study or adversely impact study results. Key Exclusion Criteria: * Human immunodeficiency virus (HIV) infection, as shown by the presence of anti-HIV antibody (seropositive). * Seropositive for hepatitis B virus (HBV) (hepatitis B surface antigen positive at screening) or hepatitis C virus (HCV) (HCV antibody positive with reflex confirmation using HCV RNA amplification at Screening). Cured HCV (positive antibody test without detectable HCV RNA) is permitted if HCV RNA has been negative for at least 2 years. * Uncontrolled hypertension (resting systolic blood pressure ≥160 millimeters of mercury \[mmHg\] or diastolic blood pressure ≥95 mmHg, confirmed by repeat measurement, at Screening). * Evidence of clinically significant immunocompromising condition (for example, primary immunodeficiency syndrome, aplastic anemia, known or suspected complement factor deficiency, or any other condition resulting in significantly impaired immune response as evidenced by recurrent infections), or recent/ongoing treatment with immunosuppressive agents. * History of major surgery within 90 days of Screening. * Use of an investigational agent or device within 30 days or 5 half-lives (whichever is longer) prior to dosing or current participation in an investigational study. Participants recently participating in studies involving investigational agents with prolonged therapeutic effect (such as ribonucleic acid interference \[RNAi\] therapeutics, cell or gene therapies) should be discussed with the Medical Monitor. * Any medical condition or clinically significant laboratory abnormality at Screening that in the opinion of the Investigator should exclude the participant from participation, preclude safe and successful completion of the study, or confound study results. Note: Other protocol-defined inclusion and exclusion criteria may apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07662096 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07662096 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07662096 currently recruiting?
Yes, NCT07662096 is actively recruiting participants. Contact the research team at ARO033-1001@arrowheadpharma.com for enrollment information.
Where is the NCT07662096 trial being conducted?
This trial is being conducted at Auckland, New Zealand.
Who is sponsoring the NCT07662096 clinical trial?
NCT07662096 is sponsored by Arrowhead Pharmaceuticals. The trial plans to enroll 42 participants.