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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05533294




Registration number
NCT05533294
Ethics application status
Date submitted
6/09/2022
Date registered
9/09/2022
Date last updated
29/03/2024

Titles & IDs
Public title
Study of ARO-RAGE in Healthy Subjects
Scientific title
A Phase 1 Study Evaluating the Effects of ARO-RAGE Injection for Subcutaneous Administration in Healthy Subjects
Secondary ID [1] 0 0
ARORAGE-1002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ARO-RAGE Injection
Treatment: Drugs - Placebo

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

Placebo Comparator: Placebo - placebo calculated volume to match active treatment by sc injection


Treatment: Drugs: ARO-RAGE Injection
ARO-RAGE injection for sc administration

Treatment: Drugs: Placebo
normal saline (0.9% NaCl) by sc injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
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 outcome [1] 0 0
Change from Baseline Over Time in Forced Expiratory Volume (FEV1)
Timepoint [1] 0 0
Baseline through EOS (up to 113 days or until serum SRAGE is =70% of baseline value, whichever is later)
Secondary outcome [2] 0 0
Change from Baseline Over Time in Forced Vital Capacity (FVC)
Timepoint [2] 0 0
Baseline through EOS (up to 113 days or until serum SRAGE is =70% of baseline value, whichever is later)
Secondary outcome [3] 0 0
Change from Baseline Over Time in Diffusing Capacity for Carbon Monoxide (DLCO)
Timepoint [3] 0 0
Baseline through EOS (up to 113 days or until serum SRAGE is =70% of baseline value, whichever is later)
Secondary outcome [4] 0 0
PK of ARO-RAGE: Maximum Observed Plasma Concentration (Cmax)
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
PK of ARO-RAGE: Area Under the Plasma Concentration versus Time Curve From Zero to 24 Hours (AUC0-24)
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
PK of ARO-RAGE: Area Under the Plasma Concentration versus Time Curve From Zero to the Last Quantifiable Plasma Concentration (AUClast)
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
PK of ARO-RAGE: Area Under the Plasma Concentration versus Time Curve From Zero to Infinity (AUCinf)
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
PK of ARO-RAGE: Terminal Elimination Half-Life (t1/2)
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
PK of ARO-RAGE: Apparent Systemic Clearance (CL/F)
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
PK of ARO-RAGE: Apparent Terminal-Phase Volume of Distribution (VZ/F)
Timepoint [10] 0 0
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

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/02/2024
Sample size
Target
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Aukland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arrowhead Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05533294
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries