A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults With Dyslipidemia
Dyslipidemia
active
ID: NCT05413135
This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continue to meet eligibility criteria have the option to be enrolled into this study. Eligible enrolled participants will initially receive open-label ARO-APOC3 at the assigned dose level until a final dose is selected, at which point all participants will be transitioned to the selected dosing regimen.
Inclusion Criteria
Adults who are nonpregnant, nonlactating and do not plan to become pregnant during the study
Able and willing to provide written informed consent
Completed the 48-week study treatment period in the parent study
Trial Details
Locations:
Australia, Canada, Hungary, Netherlands, New Zealand, Poland, United States
Eligibility criteria:
18 Years and older (Adult, Older Adult), All sexes, No healthy volunteers
active
A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults With Dyslipidemia
Dyslipidemia
ID: NCT05413135
This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continue to meet eligibility criteria have the option to be enrolled into this study. Eligible enrolled participants will initially receive open-label ARO-APOC3 at the assigned dose level until a final dose is selected, at which point all participants will be transitioned to the selected dosing regimen.
Phase 2 Study to Evaluate the Safety and Efficacy of ARO-ANG3 in Subjects With Homozygous Familial Hypercholesterolemia (HOFH)(Gateway)
Homozygous Familial Hypercholesterolemia
active
ID: NCT05217667
Participants with documented homozygous familial hypercholesterolemia (HoFH) who have provided informed consent will receive 2 open-label doses of ARO-ANG3 and be evaluated for safety and efficacy parameters through 36 weeks. Participants who complete the first 36 week treatment period may opt to continue in an additional 24-month extension period during which they will receive up to 8 doses open-label doses of ARO-ANG3.
Inclusion Criteria
Fasting LDL-C >100 mg/dL at Screening
Weight of ≥ 40 kg and body mass index ≥ 18.5 and ≤ 40 kg/m2
Diagnosis of HoFH based on a supportive genetic test or clinical diagnosis
On stable maximally tolerated lipid lowering therapy
Willing to abide by stable low-fat, low-cholesterol, heart-healthy diet for at least 4 weeks prior to Day 1
Participants of childbearing potential (males & females) must agree to use highly-effective contraception during the study and for at least 24 weeks from the last dose of study medication.
Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding
Women of childbearing potential on hormonal contraceptives must be stable on the medications for > 2 menstrual cycles prior to Day 1
Willing to provide written informed consent and to comply with study requirements
Trial Details
Locations:
Australia, Canada, South Africa, United States
Eligibility criteria:
16 Years and older (Child, Adult, Older Adult), All Sexes, No Healthy Volunteers
active
Phase 2 Study to Evaluate the Safety and Efficacy of ARO-ANG3 in Subjects With Homozygous Familial Hypercholesterolemia (HOFH)(Gateway)
Homozygous Familial Hypercholesterolemia
ID: NCT05217667
Participants with documented homozygous familial hypercholesterolemia (HoFH) who have provided informed consent will receive 2 open-label doses of ARO-ANG3 and be evaluated for safety and efficacy parameters through 36 weeks. Participants who complete the first 36 week treatment period may opt to continue in an additional 24-month extension period during which they will receive up to 8 doses open-label doses of ARO-ANG3.
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
recruiting
A Phase 1/2a Study Evaluating the Effects of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease
Inflammatory Pulmonary Diseases
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 1/2a Study Evaluating the Effects of ARO-MUC5AC Inhalation Solution in Healthy Subjects and Patients With Muco-Obstructive Lung Disease
Chronic Obstructive Pulmonary Disease
recruiting
ID: NCT05292950
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of ARO-MUC5AC in normal healthy volunteers (NHVs), patients with moderate-to-severe asthma and patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In part 1 NHVs will receive a single dose of ARO-MUC5AC or placebo. In part 2 of the study, NHVs, adult patients with asthma, and adult patients with COPD will receive 3 doses of ARO-MUC5AC or placebo.
Inclusion Criteria
Normal pulmonary function tests at Screening (NHVs only)
Confirmed diagnosis of asthma or COPD based on source verifiable medical record (asthma and COPD patients only)
No abnormal finding of clinical relevance at Screening (NHVs only)
Stable dose of asthma controller medications for at least 28 days prior to Screening (asthma patients only)
Documented treatment with an inhaled corticosteroid and at least 1 additional maintenance asthma controller medication for at least 3 months prior to Screening (asthma patients only)
Non-smoking (NHVs and asthma patients)
Current smoker or ex-smoker with smoking history of ≥ 10 pack-years (COPD patients only)
All COPD treatments have been stable for at least one month prior to Screening (COPD patients only)
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, Poland, Thailand
Eligibility criteria:
18 Years to 70 Years (Adult, Older Adult), All Sexes, Accepts Healthy Volunteers
recruiting
A Phase 1/2a Study Evaluating the Effects of ARO-MUC5AC Inhalation Solution in Healthy Subjects and Patients With Muco-Obstructive Lung Disease
Chronic Obstructive Pulmonary Disease
ID: NCT05292950
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of ARO-MUC5AC in normal healthy volunteers (NHVs), patients with moderate-to-severe asthma and patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In part 1 NHVs will receive a single dose of ARO-MUC5AC or placebo. In part 2 of the study, NHVs, adult patients with asthma, and adult patients with COPD will receive 3 doses of ARO-MUC5AC or placebo.
A Phase 1 Study Evaluating the Effects of ARO-RAGE Injection for Subcutaneous Administration in Healthy Subjects
Asthma
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
Asthma
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.
A Phase 1/2a Study Evaluating the Effects of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
recruiting
ID: NCT05537025
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ARO-MMP7 in normal healthy volunteers (NHVs) and in participants with idiopathic pulmonary fibrosis (IPF). The study will initiate with NHVs receiving single ascending doses of ARO-MMP7. Following evaluation of safety and pharmacodynamic (PD) data, participants will receive multiple doses of ARO-MMP7.
Inclusion Criteria (NHVs)
Normal pulmonary function tests at Screening
Normal electrocardiogram (ECG) at Screening
Non-smoking
Female participants cannot be pregnant or lactating
Male and female participants of childbearing potential must agree to use highly effective contraception and must not donate eggs/sperm during the study and for at least 90 days following end of study or last dose of study drug, whichever is later.
Inclusion Criteria (IPF Participants)
Age ≥ 45 years at Screening
Clinical diagnosis consistent with IPF based upon established criteria confirmed by review of high-resolution computed tomography (HRCT) and surgical lung biopsy findings (if available)
Safely able to undergo bronchoscopy
Stable IPF disease at Screening with minimum life expectancy of ≥ 12 months from Screening
Female participants cannot be pregnant or lactating
Male and female participants of childbearing potential must agree to use highly effective contraception and must not donate eggs/sperm during the study and for at least 90 days following end of study or last dose of study drug, whichever is later.
Trial Details
Eligibility criteria:
18 Years and older (Adult, Older Adult), all sexes, accepts healthy volunteers
recruiting
A Phase 1/2a Study Evaluating the Effects of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
ID: NCT05537025
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ARO-MMP7 in normal healthy volunteers (NHVs) and in participants with idiopathic pulmonary fibrosis (IPF). The study will initiate with NHVs receiving single ascending doses of ARO-MMP7. Following evaluation of safety and pharmacodynamic (PD) data, participants will receive multiple doses of ARO-MMP7.
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