Clinical trials: sponsored by Arrowhead Pharmaceuticals
IgA Nephropathy
Study of ARO-CFB in Adult Healthy Volunteers
The purpose of AROCFB-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARO-CFB Injection in adult healthy volunteers (HVs). HVs will receive either one or two doses of ARO-CFB or placebo.
- Trial name
- NCT06209177
- Testing
- ARO-CFB
- Where
- New Zealand
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Dyslipidemias
Study of ARO-APOC3 in Adults With Dyslipidemia
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 continued to meet eligibility…
- Trial name
- NCT05413135
- Testing
- ARO-APOC3
- Where
- 60 sites in United States, Australia and 5 more
- Volunteers
- 418 people
- Sponsor
- Arrowhead Pharmaceuticals
Mixed Dyslipidemia
Study of Plozasiran (ARO-APOC3) in Adults With Mixed Dyslipidemia
Participants who have met all protocol eligibility criteria will be randomly assigned to treatment (ARO-APOC3 or placebo) in a double-blind fashion and will be evaluated for safety and efficacy over 48 weeks.
- Trial name
- MUIR (NCT04998201)
- Testing
- ARO-APOC3
- Where
- 30 sites in United States, Australia and 4 more
- Volunteers
- 353 people
- Sponsor
- Arrowhead Pharmaceuticals
Asthma
Study 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 (asthma).
- Trial name
- NCT05276570
- Testing
- ARO-RAGE
- Where
- 8 sites in Australia, New Zealand and 3 more
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Severe Hypertriglyceridemia
Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia
The purpose of AROAPOC3-2001 is to evaluate the efficacy and safety of ARO-APOC3 in participants with severe hypertriglyceridemia. Participants will receive 2 subcutaneous injections of ARO-APOC3.
- Trial name
- SHASTA-2 (NCT04720534)
- Testing
- ARO-APOC3
- Where
- 74 sites in United States, Australia and 6 more
- Volunteers
- 229 people
- Sponsor
- Arrowhead Pharmaceuticals
Familial Chylomicronemia, High Risk Severe Hypertriglyceridemia (SHTG)
Treatment Protocol of Plozasiran in Adults With High-Risk Severe Hypertriglyceridemia (SHTG) and in Adults and Adolescents With FCS
This is a treatment program for the use of plozasiran in adults (AROAPOC3-EAP-002) and adolescents (AROAPOC3-EAP-003) with familial chylomicronemia syndrome (FCS) as well as in adults (AROAPOC3-EAP-004) with high risk severe…
- Trial name
- NCT06796426
- Testing
- Plozasiran
- Where
- United States
- Sponsor
- Arrowhead Pharmaceuticals
Hepatitis B
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection
Patients with chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.
- Trial name
- NCT02604199
- Testing
- ARC-520 Injection, entecavir, tenofovir
- Where
- 16 sites in China, Germany and 1 more
- Volunteers
- 58 people
- Sponsor
- Arrowhead Pharmaceuticals
Healthy
A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers
Single doses of ARC-520 will be evaluated at varying infusion rates and by slow bolus push.
- Trial name
- NCT02535416
- Testing
- ARC-520, cetirizine, diphenhydramine
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Hepatitis B, Hepatitis D
Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)
Patients with chronic HBV infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF) and/or pegylated interferon (PEG IFN) alpha 2a therapy, and be…
- Trial name
- MONARCH (NCT02577029)
- Testing
- ARC-520, entecavir, pegylated interferon alpha 2a
- Where
- 33 sites in Australia, Bulgaria and 6 more
- Volunteers
- 79 people
- Sponsor
- Arrowhead Pharmaceuticals
Hepatitis B, Chronic
A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
The purpose of this study is to determine whether ARC-520 in combination with entecavir is effective in the treatment of patients with chronic HBV Infection.
- Trial name
- NCT02065336
- Testing
- ARC-520, entecavir, chlorpheniramine
- Where
- 2 sites in Hong Kong
- Volunteers
- 58 people
- Sponsor
- Arrowhead Pharmaceuticals
Hepatitis B
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection
Patients with HBeAG positive, chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.
- Trial name
- NCT02604212
- Testing
- ARC-520, entecavir, antihistamine
- Where
- 16 sites in China, Germany and 1 more
- Volunteers
- 32 people
- Sponsor
- Arrowhead Pharmaceuticals
Hepatitis B
Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection
Chronic HBV patients will receive 9 doses of open-label ARC-520 once every 4 weeks and be evaluated for safety and efficacy.
- Trial name
- NCT02738008
- Testing
- ARC-520 Injection, entecavir, tenofovir
- Where
- 6 sites in China, Germany and 1 more
- Volunteers
- 12 people
- Sponsor
- Arrowhead Pharmaceuticals
Hepatitis B
A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)
Normal healthy volunteer (NHV) participants will enroll sequentially into a total of 6 escalating dose levels (6 subjects per dose level), randomized to receive a single dose of ARC-521 Injection or placebo.
- Trial name
- NCT02797522
- Testing
- ARC-521 Injection, antihistamine, acetaminophen
- Where
- New Zealand
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Alpha-1 Antitrypsin Deficiency
A Study of ARC-AAT in Healthy Volunteer Subjects and Patients With Alpha-1 Antitrypsin Deficiency (AATD)
The purpose of the study is to determine the safety and tolerability of escalating doses of ARC-AAT and to evaluate the pharmacokinetics of ARC-AAT and the effect of ARC-AAT on circulating levels of alpha-1 antitrypsin (AAT).
- Trial name
- NCT02363946
- Testing
- ARC-AAT Injection, Diphenhydramine
- Where
- 4 sites in Australia, Germany and 2 more
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Chronic Hepatitis B
Study of ARC-520 in Patient With Chronic Hepatitis B Virus
Patients with chronic HBV infection will receive ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.
- Trial name
- NCT02349126
- Testing
- ARC-520 Injection
- Where
- Australia
- Sponsor
- Arrowhead Pharmaceuticals
Healthy
Safety and Tolerability Study of ARC-520 in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.
- Trial name
- NCT01872065
- Testing
- ARC-520
- Where
- Australia
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Hypertriglyceridemia, Familial Chylomicronemia
Study of ARO-APOC3 in Healthy Volunteers, Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndrome (FCS)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple doses of ARO-APOC3 in healthy adult volunteers and in patients with severe hypertriglyceridemia and…
- Trial name
- NCT03783377
- Testing
- ARO-APOC3, sterile normal saline (0.9% NaCl)
- Where
- 10 sites in Australia, Canada and 1 more
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Alpha 1-Antitrypsin Deficiency
Study of ARO-AAT in Normal Adult Volunteers
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-AAT in healthy adult volunteers.
- Trial name
- NCT03362242
- Testing
- ARO-AAT Injection, Sterile Normal Saline (0.9% NaCl)
- Where
- New Zealand
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Dyslipidemias, Familial Hypercholesterolemia
Study of ARO-ANG3 in Healthy Volunteers and in Dyslipidemic Patients
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single- and multiple doses of ARO-ANG3 in healthy adult volunteers and in dyslipidemic patients including familial…
- Conditions
- Dyslipidemias, Familial Hypercholesterolemia, Hypertriglyceridemia
- Trial name
- NCT03747224
- Testing
- ARO-ANG3, sterile normal saline (0.9% NaCl)
- Where
- 6 sites in Australia, New Zealand
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Alpha-1 Antitrypsin Deficiency
Safety, Tolerability and Effect of ARC-AAT Injection on Circulating and Intrahepatic Alpha-1 Antitrypsin Levels
Patients with Alpha-1 Antitrypsin Deficiency (AATD) will be enrolled to receive multiple doses of ARC-AAT Injection. All subjects will require a pre-dose biopsy and a biopsy post last dose.
- Trial name
- NCT02900183
- Testing
- ARC-AAT Injection
- Where
- 4 sites in Canada, Ireland and 2 more
- Sponsor
- Arrowhead Pharmaceuticals