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Recruiting NCT07662096

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

Phase I Interventional Healthy Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ARO-033, Placebo.
Who it may be relevant to
Registry conditions: Healthy Participants. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A First-In-Human Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of ARO-033 in Adult Participants

Overview

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).

Interventions

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

Primary outcome measures

  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to Day 225]
Secondary outcome measures (3)
  • Maximum Observed Plasma Concentration (Cmax) of ARO-033 [Time frame: 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 [Time frame: 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) [Time frame: 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)]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

New Zealand · 1 center
  • Research Site 1 — Auckland

Identifiers

NCT: NCT07662096 · ARO033-1001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗