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ARO-033

Phase 1

Healthy Participants | Small molecule | Other |Arrowhead Pharmaceuticals, Inc.|Last Updated: Jul 22, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

ARO-033 · 1 trial · 1 indication

Phase 1 1
NCT07662096A First-In-Human Study of ARO-033 in Adult ParticipantsHealthy Participants
RECRUITING42 Analytics
PHASE1RECRUITING
A First-In-Human Study of ARO-033 in Adult Participants
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Up to Day 225

Secondary Endpoints

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)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARO-033EXPERIMENTALParticipants 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.
PlaceboPLACEBO_COMPARATORParticipants 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.

Interventions

NameTypeDescription
ARO-033DRUGARO-033 will be administered as a subcutaneous (SC) injection per schedule specified in the arm description.
PlaceboDRUGPlacebo matching to ARO-033 will be administered as SC injection per schedule specified in the arm description.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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), inc...

Countries:New Zealand
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Recent Changes (Last 90 Days)

LOWJul 22, 2026NCT07662096Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 22, 2026NCT07662096Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 23, 2026NCT07662096NEW_TRIAL: changed
LOWJun 23, 2026NCT07662096NEW_TRIAL: changed

Frequently asked questions about ARO-033

What is ARO-033 used for?

ARO-033 is an investigational small molecule being studied for use in healthy participants. It is currently in a first-in-human Phase 1 clinical trial to evaluate its safety and tolerability in adults. The drug is not yet approved and remains in clinical development.

Who makes ARO-033?

ARO-033 is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARWR. The company is conducting a first-in-human study of ARO-033 in adult participants.

What phase is ARO-033 in?

ARO-033 is in Phase 1 clinical development. It is currently being evaluated in a first-in-human study that is recruiting participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is ARO-033 in?

ARO-033 is being studied in a Phase 1 clinical trial with the identifier NCT07662096. This first-in-human study is recruiting 42 healthy adult participants in New Zealand. The trial is randomized, double-blind, and placebo-controlled.

Is ARO-033 FDA approved?

ARO-033 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial is designed to assess the safety and tolerability of ARO-033 in healthy participants, and regulatory approval has not been granted.