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

ConditionHealthy Participants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorArrowhead Pharmaceuticals

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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 (m²), 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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ARO-033

    Drug

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

  • Placebo

    Drug

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

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: ARO-033Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to Day 225

Secondary outcomes

1

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)
2

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)
3

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arrowhead Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: