Arcturus Therapeutics, Inc.
Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-032 in healthy adult subjects (Phase 1) and of two doses in Adults with Cystic Fibrosis (Phase 1b).
Cystic Fibrosis
ARCT-032
Placebo
Phase 1
Phase 1 of this study is a single ascending dose, first-in-human study to determine the safety, tolerability, and pharmacokinetics (PK) of ARCT-032. After screening, healthy adult participants will be randomized 3:1 to inhale a single dose of nebulized ARCT-032 or placebo. There are 4 planned sequential dose cohorts. After dosing, participants will have follow-up assessments over a 4-week period. Phase 1b in adults with cystic fibrosis will enroll after Phase 1 is completed and safety data are reviewed. Phase 1b is an open-label, two-dose study in adults with cystic fibrosis to assess the safety, tolerability, and pharmacokinetics of ARCT-032. After completion of screening, each participants will inhale two doses of nebulized ARCT-032 two days apart. Participants will have follow-up assessments over a 4-week period.}}
Study Type : | Interventional |
Estimated Enrollment : | 38 participants |
Masking : | Double |
Masking Description : | Participant and investigator masking only applies to Phase 1 healthy volunteers only. For Phase 1b, there is no masking, None (Open Label) should be applied. |
Primary Purpose : | Treatment |
Official Title : | A Study in Two Parts: (Phase 1) A Randomized, Double-blinded, Placebo--controlled, Single-ascending-dose Study in Healthy Adult Subjects and (Phase 1b) an Open-label, Nested, Divided-dose Study in Adults With Cystic Fibrosis to Assess the Safety, Tolerability, and Pharmacokinetics of ARCT-032 |
Actual Study Start Date : | February 15, 2023 |
Estimated Primary Completion Date : | May 30, 2024 |
Estimated Study Completion Date : | May 30, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: ARCT-032, Healthy Adults Ascending single doses of ARCT-032 administered to healthy adults via nebulizer |
Drug: ARCT-032 |
Placebo Comparator: Placebo, Healthy Adults Single doses of 0.9% Saline administered to healthy adults via nebulizer |
Other: Placebo |
Experimental: ARCT-032,. Adults with Cystic Fibrosis Two doses of ARCT-032 administered to adults with Cystic Fibrosis via nebulizer |
Drug: ARCT-032 |
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
New Zealand Clinical Research
Christchurch, New Zealand, 8011