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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06933043




Registration number
NCT06933043
Ethics application status
Date submitted
31/03/2025
Date registered
17/04/2025
Date last updated
17/04/2025

Titles & IDs
Public title
A Study on the Safety, Tolerability, Bioavailability and Mechanism of Action of Intravenous NAV-240 in Adults.
Scientific title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous NAV-240 in Healthy Participants
Secondary ID [1] 0 0
NAV-240-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NAV-240
Treatment: Drugs - Placebo

Experimental: NAV-240 - Participants will be enrolled in 1 of 3 multiple ascending dose cohorts. Six participants in each cohort will receive NAV-240.

Placebo comparator: Placebo to match NAV-240 - In each multiple ascending dose cohort, 2 participants will receive matching placebo.


Treatment: Drugs: NAV-240
Three doses of intravenous (IV) low dose, medium dose or high dose NAV-240 will be administered to participants.

Treatment: Drugs: Placebo
Three doses of matching placebo will be administered to participants.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence and severity of any treatment-emergent adverse events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Through 6 weeks after last dose of study drug.
Secondary outcome [1] 0 0
Pharmacokinetics parameter - maximum observed concentration (Cmax)
Timepoint [1] 0 0
Through to Day 99.
Secondary outcome [2] 0 0
Pharmacokinetics parameter - Time for maximum observed Concentration (Tmax)
Timepoint [2] 0 0
Through to Day 99.
Secondary outcome [3] 0 0
Pharmacokinetics parameter - Area under the curve (AUC)
Timepoint [3] 0 0
Through to Day 99.
Secondary outcome [4] 0 0
Pharmacokinetics parameter - Volume of distribution (Vz)
Timepoint [4] 0 0
Through to Day 99.
Secondary outcome [5] 0 0
Immunogenicity of study drug - Anti-Drug Antibodies (ADAs)
Timepoint [5] 0 0
Through to Day 99.

Eligibility
Key inclusion criteria
Selected

* Male and female participants 18 - 65 years of age
* Medically healthy, in the opinion of the Investigator, with no clinically significant findings on medical history, physical examination, vital signs, or electrocardiograms (ECGs) at Screening, and/or before administration of the initial dose of study drug.
* Participants must have clinical laboratory values within normal ranges of upper limit of normal (ULN) as specified by the testing laboratory, unless deemed not clinically significant (NCS) by the Investigator.
* Body mass index (BMI) 18 to =35 kg/m2 at Screening.
* Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1.
* Female participants of childbearing potential who are sexually active with a male partner of reproductive potential must agree to the use highly effective method of contraception established from at least 28 days prior to screening until at least 90 days after study drug dosing.
* Male participants with female partners who are of reproductive potential must agree to the use of a male condom PLUS a highly effective, method of contraception for the duration of the study, and for at least 90 days after study drug dosing. Male healthy participants also must agree to refrain from sperm donation during the study and for at least 90 days after study drug dosing. Note: Males who are surgically sterile (i.e., documented successful vasectomy) will also be required to use a male condom. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
* Participants must provide signed informed consent prior to study entry and have the ability and willingness to attend and comply with the necessary visits at the study site. They must also receive a copy of the fully executed informed consent document.

Selected
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* A relevant history of severe respiratory disease that required treatment and/or follow up under the direction of a physician.
* Any neurological, psychiatric, vascular, or system disorder that could also affect the evaluation of disease activity assessments.
* Any other significant acute or chronic medical illness that, in the opinion of the Investigator, would impact the participant's ability to complete all study requirements or that might impact the assessment of study data, or the participant has had a clinically significant illness within 30 days prior to study drug dosing per the Investigator's discretion.
* History of alcoholism or drug abuse within the prior 2 years.
* Acute COVID infection (within three months of Screening) or long COVID.
* A history and/or current presence of a clinically significant atopic allergy, hypersensitivity, or allergic reactions.
* Known or suspected clinically relevant drug hypersensitivity to any components of the test and reference investigational product formulation or comparable drugs.
* A history of any infection requiring hospitalization, IV or oral antibiotics, or as otherwise judged clinically significant, within the 3 months prior to Screening, or an opportunistic infection within the past 12 months, or ongoing infection including chronic viral disease.
* A positive test result for drugs of abuse, cotinine, or alcohol at Screening and on Day -1.
* Active tuberculosis (TB) or a history of TB, or a positive TB blood test at Screening.
* Systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg confirmed by repeat.
* Abnormalities on 12-lead echocardiogram (ECG) prior to study drug dosing, confirmed by repeat.
* All prescription and over-the-counter medications (including vitamins and dietary or herbal supplements), except for contraceptives and acetaminophen, as needed, are prohibited within 7 days prior to the first study drug administration and throughout the treatment period of the study.
* Received vaccines (whether live, attenuated, or killed/inactivated) within 4 weeks prior to Day 1 or is planning to receive any vaccine over the course of the study. Note, influenza vaccines (inactivated) will be allowed during the study.
* Received anti-TNF therapy in the past, confirmed by participant and Investigator.
* Receipt of any investigational drug within 30 days prior to Screening or 5 half-lives, whichever is longer.
* Females who are pregnant or breastfeeding.
* Active cigarette smoker or has regularly used nicotine or nicotine-containing products
* Any reason which, in the opinion of the Investigator, would prevent the healthy participant from participating in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
13/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/11/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Nucleus Network - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Southern Star Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Navigator Medicines, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jillian Chapas-Reed
Address 0 0
Country 0 0
Phone 0 0
+ 1 410-920-2475
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06933043