A Study on the Safety, Tolerability, Bioavailability and Mechanism of Action of subcutaneous NAV-242 in adults with Hidradenitis Suppurativa.
A Phase 1, Multiple Dose Open Label Study of Subcutaneous NAV-242 in Participants with Hidradenitis Suppurativa.
Navigator Medicines
6 participants
Oct 14, 2026
Interventional
Conditions
Summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of NAV 242 participants with HS. Approximately 6 participants with HS (1 cohort with 6 participants). Each part of the study will include a screening period of up to 6 weeks, a treatment period of 60 days and a follow up period of 24 weeks .The approximate total study duration is 38 weeks for each participant.
Eligibility
Inclusion Criteria8
- Male and female aged 27 to 65 years (inclusive) at the time of informed consent.
- History of HS for greater than or equal to 6 months from Screening as determined by the Investigator (e.g., through medical history, interview of participant).
- HS lesions in at least 2 distinct anatomical regions, one of which must be Hurley Stage II or Hurley Stage III.
- Antibiotics:
- a. Participants using oral antibiotics for the treatment of HS may continue use during the study as long as the dose remains stable from 4 weeks prior to Day 1 and is considered likely to remain stable for the duration of the study.
- b. Topical HS treatments, including over-the-counter antiseptics (e.g., chlorhexidine, triclosan, benzoyl peroxide, diluted bleach in water) and topical prescription treatments (e.g., corticosteroids and antibiotics) are allowed but not required.
- Female participants of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.
- Willing and able to provide written informed consent.
Exclusion Criteria29
- A relevant history of severe respiratory disease.
- Any neurological, psychiatric, vascular, or system disorder that could also affect the evaluation of disease activity assessments.
- History or evidence of an immunodeficiency disorder
- Any other significant acute or chronic medical illness that might impact the participant’s ability to complete all study requirements, participant safety or data
- History of alcoholism or drug abuse
- A history and/or current presence of a clinically significant atopic allergy, hypersensitivity, or allergic reactions.
- Known or suspected clinically relevant drug hypersensitivity to IP
- A history of any infection requiring hospitalization, IV or oral antibiotics, or as otherwise judged clinically significant
- A history of malignancy.
- A history of New York Heart Association (NYHA) Class II, III or IV heart failure, active diabetes mellitus, active thyroid disease or cognitive impairment
- A history of osteoporosis or previous treatment for spontaneous/atraumatic fractures, pathological fractures, or any recent fractures (within 6months from Day 1).
- Positive serology tests (HIV), syphilis, hepatitis B or hepatitis C virus antibody.
- Positive anti-adalimumab antibody at Screening.
- Clinically significant abnormality in bone turnover biomarkers at Screening, in the opinion of the Investigator.
- A positive test result for drugs of abuse, cotinine, or alcohol at Screening and on Day -1.
- Active TB or a history of TB, or a positive TB blood test at Screening.
- 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.
- Received anti-TNF-a 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 other nicotine use
- Has had major surgery, including HS surgery, within 12 weeks prior to Day 1 or major surgery is planned over the period of the study.
- Participants with a diagnosis of systemic inflammatory conditions other than HS,
- History of central or peripheral demyelinating disease, including multiple sclerosis and optic neuritis, and Guillain-Barré syndrome.
- History of moderate to severe heart failure (New York Heart Association class II, III or IV) or recent cerebrovascular accident.
- History of or active suicidal ideation OR History of or active psychiatric condition
- Has received any glucagon-like peptide-1 (GLP-1) receptor agonist within 6 weeks or 5 half-lives (whichever is longer) prior to Day 1.
- Has received any immunomodulatory biologic agent or systemic nonbiologic immunomodulatory medication
- Prior exposure to biologics that have a potential or known association with progressive multifocal leukoencephalopathy
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Interventions
This is a Phase 1 open label study to evaluate the safety, tolerability, Pharmacokinetics (PK), Pharmacodynamic(PD), and immunogenicity of NAV-242 in participants with Hidradenitis Suppurativa (HS). 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 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. Participants will receive up to 2 doses of NAV-242 at an 8-week interval. Participants will receive 2 doses unless they are withdrawn from the study prior to the administration of the 2nd dose. The dose will be administered via subcutaneous (SC) injection by appropriately trained clinical site staff and participants will be monitored in an inpatient setting. The first dose 600mg (6mL) 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. 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 1unit for72-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 on days 8, 15, 29, 64, 71, 85, 113, 141, 169, 197 and End Of Study (EOS) visit on Day 225.
Locations(1)
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ACTRN12626000154303