search
Back to results

Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects

Primary Purpose

Cystic Fibrosis

Status
Recruiting
Phase
Phase 1
Locations
New Zealand
Study Type
Interventional
Intervention
ARCT-032
Placebo
Sponsored by
Arcturus Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, CF

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria: Healthy males or females aged 18 to 65 at the time of informed consent Body weight between 40-100Kg and body mass index between 16-35 kg/m2 Forced expiratory volume (FEV1) >85% of predicted value for age, sex, and height Surgically sterile or using an acceptable contraceptive method from the time of signing the informed consent form until at least 30 days after the last dose of Study Drug. Key Exclusion Criteria: History of illness or condition that might pose an additional risk or may confound study results. Pregnant or lactating (breast feeding) History of severe allergic reaction to a liposomal product Clinically significant abnormalities in Screening laboratory results Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B Treatment with another investigational drug, biological agent, or device within 30 days of screening, or 5 half-lives of investigational drug, whichever is longer Drug or alcohol abuse within the past year History of moderate to heavy smoking or vaping (>10 cigarettes/sessions per day) within 6 months prior to the dose of study drug. Participants must be willing to refrain from smoking or vaping within 1 week of dosing through Day 15 Systemic or inhaled corticosteroids within 3 months prior to screening. Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study

Sites / Locations

  • New Zealand Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ARCT-032

Placebo

Arm Description

Ascending single doses of ARCT-032 administered via nebulizer

Single doses of 0.9% Saline administered via nebulizer

Outcomes

Primary Outcome Measures

Incidence, severity and dose-relationship of AEs
Safety and tolerability of ARCT-032 assessed by determining the incidence, severity and dose-relationship of AEs by dose

Secondary Outcome Measures

Change in plasma area under the curve after single dose of ARCT-032
Area under the plasma concentration versus time curve (AUC) from time zero to the last quantifiable time point
Maximum observed plasma concentration (Cmax) after single dose of ARCT-032
The maximum observed plasma concentration (Cmax)
Time at which Cmax occurred after single dose of ARCT-032
The time at which Cmax occurred (Tmax)
AUC0-inf after single dose of ARCT-032
AUC from time zero extrapolated to infinity
T1/2 after single dose of ARCT-032
Terminal half-life
CL after single dose of ARCT-032
Total body clearance, calculated as dose divided by AUC0-inf
Vss after single dose of ARCT-032
Volume of distribution

Full Information

First Posted
January 26, 2023
Last Updated
April 6, 2023
Sponsor
Arcturus Therapeutics, Inc.
Collaborators
Novotech CRO
search

1. Study Identification

Unique Protocol Identification Number
NCT05712538
Brief Title
Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects
Official Title
A Phase 1 Randomized, Double Blinded, Placebo Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Doses of ARCT-032 in Healthy Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arcturus Therapeutics, Inc.
Collaborators
Novotech CRO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-032 in healthy adult subjects.
Detailed Description
This is a single ascending dose, first-in-human study to determine the safety, tolerability, and pharmacokinetics (PK) of ARCT-032. After screening, participants will be randomized 3:1 to receive a single dose of nebulized ARCT-032 or placebo by inhalation. There are 4 planned sequential dose cohorts. After dosing, participants will have follow-up assessments over a 4-week time period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, CF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, placebo controlled
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARCT-032
Arm Type
Experimental
Arm Description
Ascending single doses of ARCT-032 administered via nebulizer
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single doses of 0.9% Saline administered via nebulizer
Intervention Type
Drug
Intervention Name(s)
ARCT-032
Intervention Description
ARCT-032 is messenger RNA (mRNA) coding for cystic fibrosis transmembrane conductance regulator (CFTR) protein, formulated in a lipid nanoparticle (LNP).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
Incidence, severity and dose-relationship of AEs
Description
Safety and tolerability of ARCT-032 assessed by determining the incidence, severity and dose-relationship of AEs by dose
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in plasma area under the curve after single dose of ARCT-032
Description
Area under the plasma concentration versus time curve (AUC) from time zero to the last quantifiable time point
Time Frame
Up to 2 Weeks
Title
Maximum observed plasma concentration (Cmax) after single dose of ARCT-032
Description
The maximum observed plasma concentration (Cmax)
Time Frame
Up to 2 Weeks
Title
Time at which Cmax occurred after single dose of ARCT-032
Description
The time at which Cmax occurred (Tmax)
Time Frame
Up to 2 Weeks
Title
AUC0-inf after single dose of ARCT-032
Description
AUC from time zero extrapolated to infinity
Time Frame
Up to 2 Weeks
Title
T1/2 after single dose of ARCT-032
Description
Terminal half-life
Time Frame
Up to 2 Weeks
Title
CL after single dose of ARCT-032
Description
Total body clearance, calculated as dose divided by AUC0-inf
Time Frame
Up to 2 Weeks
Title
Vss after single dose of ARCT-032
Description
Volume of distribution
Time Frame
Up to 2 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: Healthy males or females aged 18 to 65 at the time of informed consent Body weight between 40-100Kg and body mass index between 16-35 kg/m2 Forced expiratory volume (FEV1) >85% of predicted value for age, sex, and height Surgically sterile or using an acceptable contraceptive method from the time of signing the informed consent form until at least 30 days after the last dose of Study Drug. Key Exclusion Criteria: History of illness or condition that might pose an additional risk or may confound study results. Pregnant or lactating (breast feeding) History of severe allergic reaction to a liposomal product Clinically significant abnormalities in Screening laboratory results Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B Treatment with another investigational drug, biological agent, or device within 30 days of screening, or 5 half-lives of investigational drug, whichever is longer Drug or alcohol abuse within the past year History of moderate to heavy smoking or vaping (>10 cigarettes/sessions per day) within 6 months prior to the dose of study drug. Participants must be willing to refrain from smoking or vaping within 1 week of dosing through Day 15 Systemic or inhaled corticosteroids within 3 months prior to screening. Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Constance Crowley
Phone
+1 858.218.4590
Email
connie@arcturusrx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Terri Hopkins
Phone
+1 267.257.7676
Email
terri@arcturusrx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Schwabe, MD
Organizational Affiliation
New Zealand Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Zealand Clinical Research
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Schwabe, MD
Phone
+ 64 9 373 3474
Email
christian.schwabe@nzcr.co.nz
First Name & Middle Initial & Last Name & Degree
Olivia Dempster
Email
arctic@nzcr.co.nz

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects

We'll reach out to this number within 24 hrs