34MM
People in the U.S. live with some form of chronic lung disease.
3rd
Leading cause of death worldwide is COPD
$170B
Is the annual cost of lung diseases in the U.S.
Our Research
ARO-RAGE
lung
Inflammatory Pulmonary Diseases
ARO-RAGE
Inflammatory Pulmonary Diseases
lung
phase 1
ARO-RAGE is designed to reduce production of the Receptor for Advanced Glycation End products (RAGE) as a potential treatment for various muco-obstructive and inflammatory pulmonary diseases.
Clinical Trials
recruiting
ID: NCT05276570
A Phase 1/2a Study Evaluating the Effects of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ARO-RAGE in normal healthy volunteers (NHVs) and in participants with inflammatory lung disease. In Part 1 of the study, NHVs will receive a single dose of ARO-RAGE or placebo. In Part 2 of the study, adult participants with inflammatory lung disease will receive 2 doses of ARO-RAGE or placebo. Additional NHVs may be randomized to receive 1 or 2 doses of ARO-RAGE or placebo at Sponsor discretion. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.
complete
ID: NCT05533294
A Phase 1 Study Evaluating the Effects of ARO-RAGE Injection for Subcutaneous Administration 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.
A Phase 1/2a Study Evaluating the Effects of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease
Inflammatory Pulmonary Diseases
recruiting
ID: NCT05276570
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ARO-RAGE in normal healthy volunteers (NHVs) and in participants with inflammatory lung disease. In Part 1 of the study, NHVs will receive a single dose of ARO-RAGE or placebo. In Part 2 of the study, adult participants with inflammatory lung disease will receive 2 doses of ARO-RAGE or placebo. Additional NHVs may be randomized to receive 1 or 2 doses of ARO-RAGE or placebo at Sponsor discretion. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.
Inclusion Criteria
Normal pulmonary function tests at Screening (NHVs only)
Confirmed diagnosis of asthma based on source verifiable medical record (asthma patients only)
No abnormal finding of clinical relevance at Screening (other than asthma for asthma patients)
Stable dose of asthma controller medications for at least 4 weeks prior to Screening (asthma patients only)
Non-smoking
Able to produce an induced sputum sample at Screening
Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception. Males must not donate sperm during the study and for at least 12 weeks following the last dose of study drug
Willing to provide written informed consent and to comply with study requirements
Trial Details
Locations:
Australia, New Zealand
Eligibility criteria:
18 Years to 65 Years, All Sexes, Accepts Healthy Volunteers
A Phase 1 Study Evaluating the Effects of ARO-RAGE Injection for Subcutaneous Administration in Healthy Subjects
Inflammatory Pulmonary Diseases
complete
ID: NCT05533294
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.
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
Trial Details
Start date:
November 2022
End date:
February 8, 2024
Eligibility criteria:
18 Years to 55 Years (Adult), All Sexes, Accepts Healthy Volunteers
Active Clinical Trials
A Phase 1/2a Study Evaluating the Effects of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease
Clinical Trials
recruiting
ID: NCT05276570
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ARO-RAGE in normal healthy volunteers (NHVs) and in participants with inflammatory lung disease. In Part 1 of the study, NHVs will receive a single dose of ARO-RAGE or placebo. In Part 2 of the study, adult participants with inflammatory lung disease will receive 2 doses of ARO-RAGE or placebo. Additional NHVs may be randomized to receive 1 or 2 doses of ARO-RAGE or placebo at Sponsor discretion. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.
Inclusion Criteria
Normal pulmonary function tests at Screening (NHVs only)
Confirmed diagnosis of asthma based on source verifiable medical record (asthma patients only)
No abnormal finding of clinical relevance at Screening (other than asthma for asthma patients)
Stable dose of asthma controller medications for at least 4 weeks prior to Screening (asthma patients only)
Non-smoking
Able to produce an induced sputum sample at Screening
Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception. Males must not donate sperm during the study and for at least 12 weeks following the last dose of study drug
Willing to provide written informed consent and to comply with study requirements
Trial Details
Locations:
Australia, New Zealand
Eligibility criteria:
18 Years to 65 Years, All Sexes, Accepts Healthy Volunteers
recruiting
A Phase 1/2a Study Evaluating the Effects of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease
Clinical Trials
ID: NCT05276570
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ARO-RAGE in normal healthy volunteers (NHVs) and in participants with inflammatory lung disease. In Part 1 of the study, NHVs will receive a single dose of ARO-RAGE or placebo. In Part 2 of the study, adult participants with inflammatory lung disease will receive 2 doses of ARO-RAGE or placebo. Additional NHVs may be randomized to receive 1 or 2 doses of ARO-RAGE or placebo at Sponsor discretion. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.
A Phase 1 Study Evaluating the Effects of ARO-RAGE Injection for Subcutaneous Administration in Healthy Subjects
complete
ID: NCT05533294
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.
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
Trial Details
Start date:
November 2022
End date:
February 8, 2024
Eligibility criteria:
18 Years to 55 Years (Adult), All Sexes, Accepts Healthy Volunteers
complete
A Phase 1 Study Evaluating the Effects of ARO-RAGE Injection for Subcutaneous Administration in Healthy Subjects
ID: NCT05533294
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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