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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000155392
Ethics application status
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Approved
Date submitted
Help: Date submitted
12/12/2025
Date registered
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6/02/2026
Date last updated
Help: Date last updated
23/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
6/02/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
A Study on the Safety, Tolerability, Bioavailability and Mechanism of Action of subcutaneous NAV-242 in Healthy Adults.
Scientific title
A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Single and Multiple Ascending Doses of NAV-242 in Healthy Adult Participants.
Additional trial identifiers [1] 315958 0
NAV-242-101
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
autoimmune disease 340281 0
Condition category
Condition code
Inflammatory and Immune System 336029 336029 0 0
Autoimmune diseases
Skin 336429 336429 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This is a Phase 1 study to evaluate the safety, tolerability, PK, PD, and immunogenicity of NAV-242 in healthy participants. The study is divided into two parts:
• Part A - a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy adult participants. Each participant enrolled in Part A will receive a single dose of the study drug via subcutaneous (SC) injection or intravenous infusion (IV).
• Part B - a randomized, double-blind, placebo-controlled, multiple dose study in healthy adult participants. Participants enrolled in Part B will receive up to 2 doses of the study drug 8 weeks apart, administered subcutaneously.

Each part of the study will include a screening period, a treatment period, and a follow-up period.

After signing the informed consent, participants will be screened over a period of up to 6 weeks prior to admission into the Phase 1 unit. During the screening period, medical history will be reviewed and tests/assessments will be done to determine if eligibility for the study is met. On Day -1, eligible participants will be admitted to the Phase 1 unit prior to administration of the study drug.

For participants in Part A (SAD): Part A has 7 cohorts, corresponding to different dose levels of NAV-242 that will be administered via subcutaneous (SC) injection or Intravenous Infusion (IV). Cohort A1-A5 will receive the following doses via SC injection: Cohort A1 100mg (1mL), Cohort A2 300mg (3mL), Cohort A3 600 mg (6mL), Cohort A4 800mg (8mL) and Cohort A5 1000mg (10mL). Cohort A6-A7 will receive the following doses via Intravenous Infusion: Cohort A6 3.8mg/kg (IV) and Cohort A7 8.8mg/kg (IV). The single dose will be administered on Day 1 in an inpatient setting. Participants will remain in the Phase 1 unit from Day -1 to Day 4, and will be discharged on Day 4 following 72-hour post-dose safety evaluation and PK sample collection.

For participants in Part B: Part B has 2 cohorts, each with a single dose level and interval of NAV-242, administration via subcutaneous (SC) injection. Cohort B1 is an 8-week interval between a first dose of 600mg (6mL) and second dose of 300mg (3mL), and Cohort B2 is an 8 week interval between a first dose of 800mg (8mL) and second dose of 800mg (8mL). Participants will have their first dose administered on Day 1 in an inpatient setting. Participants will remain in the Phase 1 unit from Day -1 to Day 4, and will be discharged on Day 4 following 72-hour post-dose safety evaluation and PK sample collection.

The second doses of study drug will be administered on Day 57. Participants will check-in to the Phase 1 unit the day before administration of the second dose and remain in the Phase 1 unit for 72-hours post dosing for safety evaluation and PK sample collection (Days 56-60).

Following each dose, all participants will return for outpatient follow-up visits and the End of study (EOS) visit:

Part A, all cohorts: Outpatient follow-up visits on days 8, 15, 29, 57, 85, 113, 141, 169, 197 and EOS visit on Day 225

Part B: Outpatient follow-up visits on days 8, 15, 29, 64, 71, 85, 113, 141, 169, 197, 225, 253 and EOS visit on Day 281.
Intervention code [1] 332577 0
Treatment: Drugs
Description of the comparator or control
Placebo for subcutaneous injection and intravenous infusion, administered in the same volume as the active drug, no dilution is required for subcutaneous injection, dilution for IV will be as per the active dose. The placebo composition is as follows:
- 25 mM histidine - histidine hydrochloride
- 90 mg/mL sucrose
- 0.2 mg/mL polysorbate 80 (II)
- water for injection
Control group
Placebo

Outcomes
Primary outcome [1] 343579 0
To evaluate the safety and tolerability of subcutaneous and Intravenous doses of NAV-242 in healthy participants by the incidence of Treatment Emergent Adverse Events.
Timepoint [1] 343579 0
Part A, all cohorts: TEAEs daily from Day -1 to Day 4 and during Days 8, 15, 29, 57, 85, 113, 141, 169, 197, 225 (EOS) post first dose. Part B, all cohorts: TEAEs daily from Day -1 to Day 4 and Day 56 to Day 60, and Days 8, 15, 29, 64, 71, 85, 113, 141, 169, 197, 225, 253 and 281 (EOS) post first dose.
Primary outcome [2] 343955 0
To evaluate the safety and tolerability of subcutaneous doses of NAV-242 in healthy participants by the incidence of SAEs, including clinically significant abnormal lab findings.
Timepoint [2] 343955 0
UpdatePart A, all cohorts: SAEs, and laboratory testing daily from Day -1 to Day 4 and during Days 8, 15, 29, 57, 85, 113, 141, 169, 225 post-dose (EOS). Part B, all cohorts: SAEs, laboratory testing daily from Day -1 to Day 4 and Day 56 to Day 60, and Days 8, 15, 29, 64, 71, 85, 113, 141, 169, 197, 225, and 281 post-first dose (EOS).
Secondary outcome [1] 454806 0
To characterize the serum pharmacokinetic profile of NAV-242 in healthy participants
Timepoint [1] 454806 0
Part A, all cohorts: Day 1 within 2 hrs of dosing (or immediately at the end of infusion), then 2hr, 6hr, 12hr, 24hr, 48hr, 72hr, 168hr, 336hr, 672hr, 1344hr, 2016hr, 2688hr, 3360hr, 4032hr and 5376hr post-dose Part B, all cohorts: Day 1 within 2 hrs of dosing, then 2hr, 6hr, 12hr, 24hr, 48hr, 72hr, 168hr, 336hr, 672hr, 1344hr within 2 hrs of second dosing and, 1346hr, 1350hr, 1356hr, 1368hr, 1392hr, 1416hr, 1512hr, 1680hr, 2016hr, 2688hr, 3360hr, 4032hr, 4704hr, 5376hr, 6720 post-first dose
Secondary outcome [2] 454807 0
To evaluate the immunogenicity of NAV 242 in healthy participants by the incidence of ADAs
Timepoint [2] 454807 0
Part A, all cohorts: within 2 hrs of dosing and 672hr, 1344hr, 2016hr, 2688hr, 3360hr, 4032hr, 5376hr post dose. Part B, all cohorts: within 2 hrs of first dose, 672hr post first dose, within 2 hrs of second dose (1344hr), 2016hr, 2688hr, 3360hr, 4032h, 4704hr, 5376hr, 6720hr post-first dose.
Secondary outcome [3] 456239 0
To evaluate the immunogenicity of NAV 242 in healthy participants by the ADA titers.
Timepoint [3] 456239 0
Part A, all cohorts: within 2 hrs of dosing and 672hr, 1344hr, 2016hr, 2688hr, 3360hr, 4032hr, 5376hr post dose. Part B, all cohorts: within 2 hrs of first dose, 672hr post first dose, within 2 hrs of second dose (1344hr), 2016hr, 2688hr, 3360hr, 4032h, 4704hr, 5376hr, 6720hr post-firs dose.

Eligibility
Key inclusion criteria
1. Male or female 27- 65 years of age (inclusive) at the time of informed consent.
2. 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.
3. Participants must have clinical laboratory values within normal ranges as specified by the testing laboratory, unless deemed not clinically significant (NCS) by the Investigator.
4. Body mass index (BMI) 18 to 35 kg/m2 at Screening.
5. Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1.
6. Willing and able to provide written informed consent.
Minimum age
27 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
1. A relevant history of severe respiratory disease.
2. Any neurological, psychiatric, vascular, or system disorder that could also affect the evaluation of disease activity assessments.
3. History or evidence of an immunodeficiency disorder
4. Any other significant acute or chronic medical illness that might impact the participant’s ability to complete all study requirements, participant safety or data
5. History of alcoholism or drug abuse
6. A history and/or current presence of a clinically significant atopic allergy, hypersensitivity, or allergic reactions.
7. Known or suspected clinically relevant drug hypersensitivity to IP
8. A history of any infection requiring hospitalization, IV or oral antibiotics, or as otherwise judged clinically significant
9. A history of malignancy.
10. A history of New York Heart Association (NYHA) Class II, III or IV heart failure, active diabetes mellitus, active thyroid disease or cognitive impairment
11. A history of osteoporosis or previous treatment for osteoporosis, spontaneous/atraumatic fractures, pathological fractures, or any recent fractures (within 6months from Day 1).
12. Positive serology tests (HIV), syphilis, hepatitis B or hepatitis C virus antibody.
13. Positive anti-adalimumab antibody at Screening.
14. Clinically significant abnormality in bone turnover biomarkers at Screening, in the opinion of the Investigator.
15. A positive test result for drugs of abuse, cotinine, or alcohol at Screening and on Day -1.
16. Active TB or a history of TB, or a positive TB blood test at Screening.
17. Has received a live (attenuated) vaccine within 6 weeks prior to Day 1 or is expected to receive a live vaccine during the study and up to 90 days post last dose. Note, mRNA vaccines and influenza vaccines (inactivated) will be allowed during the study.
18. Received anti-TNF-a therapy in the past, confirmed by participant and Investigator.
19. Receipt of any investigational drug within 30 days prior to Screening or 5 half-lives, whichever is longer.
20. Females who are pregnant or breastfeeding.
21. Active cigarette smoker or other nicotine use

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)
tamper-evident envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Paper-based simple randomization with fixed blocks
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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/02/2026
Actual
3/03/2026
Date of last participant enrolment
Anticipated
6/11/2026
Actual
Date of last data collection
Anticipated
19/03/2027
Actual
Sample size
Target
72
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 28812 0
Nucleus Network Brisbane Clinic - Herston
Recruitment postcode(s) [1] 45049 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 320568 0
Commercial sector/Industry
Name [1] 320568 0
Navigator Medicines
Country [1] 320568 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Navigator Medicines
Address
Country
United States of America
Secondary sponsor category [1] 323184 0
None
Name [1] 323184 0
Address [1] 323184 0
Country [1] 323184 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319111 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 319111 0
Ethics committee country [1] 319111 0
Australia
Date submitted for ethics approval [1] 319111 0
26/11/2025
Approval date [1] 319111 0
19/12/2025
Ethics approval number [1] 319111 0

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

Contacts
Principal investigator
Name 146278 0
Dr Gloria Wong
Address 146278 0
Q-Pharm Pty Ltd, Level 5, 300c Herston Road, Herston QLD 4006
Country 146278 0
Australia
Phone 146278 0
+61 7 3707 2720
Fax 146278 0
Email 146278 0
[email protected]
Contact person for public queries
Name 146279 0
Nucleus Network Brisbane
Address 146279 0
Q-Pharm Pty Ltd, Level 5, 300c Herston Road, Herston QLD 4006
Country 146279 0
Australia
Phone 146279 0
+1800 243 733
Fax 146279 0
Email 146279 0
[email protected]
Contact person for scientific queries
Name 146280 0
Jillian Chapas-Reed
Address 146280 0
Navigator Medicines, Inc. 2525 Smith Street, Scotch Plains, NJ 07076
Country 146280 0
United States of America
Phone 146280 0
+1 4109202475
Fax 146280 0
Email 146280 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.