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

NCT07662096 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ARO033-1001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Up to Day 225

Secondary Outcomes (3)

• 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

  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)

Study Arms (2)

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.

Drug: ARO-033

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.

Drug: Placebo

Interventions

ARO-033 DRUG

ARO-033 will be administered as a subcutaneous (SC) injection per schedule specified in the arm description.

ARO-033

Placebo DRUG

Placebo matching to ARO-033 will be administered as SC injection per schedule specified in the arm description.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arrowhead Pharmaceuticals: lead

Study Sites (1)

Research Site 1

Auckland, 1010, New Zealand

RECRUITING

Central Study Contacts

Medical Monitor

CONTACT

626-304-3400; ARO033-1001@arrowheadpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 23, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): July 18, 2027
• Study Completion (Estimated): July 18, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)