Study of ARO-RAGE in Healthy Subjects

NCT05533294 | Completed Phase 1 FDA Drug

• 1 other identifier: ARORAGE-1002
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

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

  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 (10)

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

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

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

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

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

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

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

  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

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

  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

Study Arms (2)

ARO-RAGE

EXPERIMENTAL

single or multiple doses of ARO-RAGE by subcutaneous (sc) injection

Drug: ARO-RAGE Injection

Placebo

PLACEBO COMPARATOR

placebo calculated volume to match active treatment by sc injection

Drug: Placebo

Interventions

ARO-RAGE Injection DRUG

ARO-RAGE injection for sc administration

ARO-RAGE

Placebo DRUG

normal saline (0.9% NaCl) by sc injection

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arrowhead Pharmaceuticals: lead

Study Sites (1)

Research Site

Grafton, Aukland, 1010, New Zealand

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

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: September 6, 2022
• First Posted: September 9, 2022
• Study Start: November 29, 2022
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: March 29, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)