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Completed

NCT Number: NCT05533294

Study of ARO-RAGE in Healthy Subjects

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-RAGE Injection in normal healthy volunteers.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Grafton, Aukland, 1010, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal pulmonary function tests at Screening prior to sputum induction
  • Normal 12-lead electrocardiogram (ECG) at Screening
  • Non-smoking
  • Able to produce an induced sputum sample at Screening
  • Participants of child-bearing potential (male and female) must use highly effective contraception and cannot donate sperm or eggs during the study or for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. Women must have a negative pregnancy test and cannot be breastfeeding
  • Willing to provide written informed consent and to comply with study requirements

Exclusion criteria

  • Acute lower respiratory infection within 30 days prior to first dose and/or acute upper respiratory infection within 7 days prior to first dose
  • Positive COVID-19 test during Screening window
  • Chronic or acute infection that is clinically significant or requires treatment with systemic antibiotics, antivirals, antifungals, or antiparasitics within 30 days prior to first dose
  • Any history of chronic pulmonary disease
  • Use of immunosuppressive medication within 90 days prior to first dose
  • Receipt of any intranasal vaccine within 30 days prior to first dose
  • Human Immunodeficiency virus (HIV) infection, seropositive fo Hepatitis B Virus (HBV), seropositive for Hepatitis C Virus (HCV)
  • Uncontrolled hypertension
  • Use of illicit drugs
  • Unwilling to limit alcohol consumption to within moderate limits for the duration of the study
  • Use of an investigational agent or device within 30 days prior to first dose
  • Prior use of any formulation of ARO-RAGE

Note: additional inclusion/exclusion criteria may apply per protocol

Treatment and study plan

ARO-RAGE Injection

Drug

ARO-RAGE injection for sc administration

Placebo

Drug

normal saline (0.9% NaCl) by sc injection

Primary outcomes

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From first dose of study drug through the end of study (EOS; up to 113 days or until serum soluble receptor for advance glycation end products [SRAGE] is ≥70% of baseline value, whichever is later)

Secondary outcomes

  1. Change from Baseline Over Time in Forced Expiratory Volume (FEV1)

    Time frame: Baseline through EOS (up to 113 days or until serum SRAGE is ≥70% of baseline value, whichever is later)

  2. Change from Baseline Over Time in Forced Vital Capacity (FVC)

    Time frame: Baseline through EOS (up to 113 days or until serum SRAGE is ≥70% of baseline value, whichever is later)

  3. Change from Baseline Over Time in Diffusing Capacity for Carbon Monoxide (DLCO)

    Time frame: Baseline through EOS (up to 113 days or until serum SRAGE is ≥70% of baseline value, whichever is later)

  4. PK of ARO-RAGE: Maximum Observed Plasma Concentration (Cmax)

    Time frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29

  5. PK of ARO-RAGE: Area Under the Plasma Concentration versus Time Curve From Zero to 24 Hours (AUC0-24)

    Time frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29

  6. PK of ARO-RAGE: Area Under the Plasma Concentration versus Time Curve From Zero to the Last Quantifiable Plasma Concentration (AUClast)

    Time frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29

  7. PK of ARO-RAGE: Area Under the Plasma Concentration versus Time Curve From Zero to Infinity (AUCinf)

    Time frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29

  8. PK of ARO-RAGE: Terminal Elimination Half-Life (t1/2)

    Time frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29

  9. PK of ARO-RAGE: Apparent Systemic Clearance (CL/F)

    Time frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29

  10. PK of ARO-RAGE: Apparent Terminal-Phase Volume of Distribution (VZ/F)

    Time frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29

Sponsors and collaborators

Lead sponsor

Arrowhead Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1 Study Evaluating the Effects of ARO-RAGE Injection for Subcutaneous Administration in Healthy Subjects

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 9, 2022
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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