Atopic Dermatitis (AD)Phase 1POLARIS-1NCT07904689
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
A Phase 1 study testing NOR-101 in people with Atopic Dermatitis (AD), run by North Immunology Inc. at 1 site in Australia.
Trial summary
This Phase 1 study will assess NOR-101, an investigational study drug, in two parts. Part 1 is a randomized, blinded study comparing single and multiple doses of NOR-101 with placebo in healthy adults. A placebo is a look-alike substance containing no active drug. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- NOR-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2026to Jan 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All: written informed consent; able to follow procedures, follow-up and contraception rules.
- Part 1: healthy adults; BMI 18 to below 32 kg/m²; weight above 50 kg; suitable injection sites; able to complete confinement and blood sampling.
- Part 2: Atopic Dermatitis for at least 12 months with inadequate response to topical prescription therapy (or such therapy unsuitable); BMI 17.5 to below 35 kg/m²; weight above 50 and below 120 kg; stable emollient use for at least 7 days without substantial improvement; washouts completed.
- Cohort 1- participants not exposed to dupilumab (eligible for systemic therapy): EASI at least 16, vIGA-AD at least 3, body surface area at least 10%, weekly peak itch score at least 4.
- Cohort 2- (dupilumab inadequate responder): at least 16 weeks of prior dupilumab; EASI at least 12, vIGA-AD at least 2, body surface area at least 5%, weekly peak itch score at least 3.
Who cannot join
- Clinically significant illness, infection, or laboratory or ECG abnormality; tuberculosis, helminth, HIV, hepatitis B or C (protocol exceptions apply).
- Exclusionary malignancy or lymphoproliferative disorder; hypersensitivity; injection intolerance.
- Recent prohibited treatments, investigational agents or live vaccines; pregnancy, breastfeeding or planned pregnancy; alcohol or drug misuse.
- Part 2: interfering skin disease or active skin infection; systemic JAK inhibitor exposure over one month or non-response.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
About this study
Official title: A Phase 1, Two-Part, First-in-Human, Randomized, Blinded, Placebo-Controlled, Single and Multiple Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of NOR-101 in Healthy Participants and Participants With Moderate-to-Severe Atopic Dermatitis.
This Phase 1 study will assess NOR-101, an investigational study drug, in two parts. Part 1 is a randomized, blinded study comparing single and multiple doses of NOR-101 with placebo in healthy adults. A placebo is a look-alike substance containing no active drug. Part 2 is an open-label, multiple-dose study in adults with moderate-to-severe atopic dermatitis (eczema). All participants in Part 2 will receive NOR-101.
Read the detailed description
POLARIS-1 (NOR-101-001) is a two-part, first-in-human study of NOR-101, an investigational study drug being developed for atopic dermatitis. Part 1 is a randomized, blinded, placebo-controlled, single-dose and multiple-dose study in healthy adults.
Part 2 is an open-label, multiple-dose study in adults with moderate-to-severe atopic dermatitis. The study evaluates safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- NOR-101, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOR-101Drug
NOR-101 will be administered
PlaceboDrug
Placebo will be administered
| Study group | Role | What they receive |
|---|---|---|
| Part 1 SAD NOR-101 | Experimental | Single dose of NOR-101 in healthy adults across planned and optional single-dose cohorts. Receives: Drug: NOR-101 |
| Part 1 SAD Placebo | Placebo comparator | Single dose of placebo in healthy adults across planned and optional single-dose cohorts. Receives: Drug: Placebo |
| Part 1 MD NOR-101 | Experimental | Multiple doses of NOR-101 in healthy adults across planned and optional multiple-dose cohorts. Receives: Drug: NOR-101 |
| Part 1 MD Placebo | Placebo comparator | Multiple doses of placebo in healthy adults across planned and optional multiple-dose cohorts. Receives: Drug: Placebo |
| Part 2 Cohort 1 NOR-101 | Experimental | Multiple doses of NOR-101 in adults with moderate-to-severe atopic dermatitis (open-label). Receives: Drug: NOR-101 |
| Part 2 Cohort 2 NOR-101 | Experimental | Multiple doses of NOR-101 in adults with moderate-to-severe atopic dermatitis (open-label) Receives: Drug: NOR-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Number of participants with adverse events, including serious adverse events, summarized by severity and relationship to study intervention in Parts 1 and 2.
Measured: From informed consent through the end of the trial (EOT), up to approximately 29 months.
Number of participants with clinically significant vital sign abnormalities
Number of participants with clinically significant vital sign abnormalities, as assessed by the investigator, in Parts 1 and 2.
Measured: Baseline through 12 months after the last dose (up to approximately 20 months).
Number of participants with clinically significant electrocardiogram abnormalities
Number of participants with clinically significant abnormalities on 12-lead electrocardiograms, as assessed by the investigator, in Parts 1 and 2.
Measured: Baseline through 12 months after the last dose (up to approximately 20 months).
Number of participants with clinically significant clinical laboratory abnormalities
Number of participants with clinically significant hematology, serum chemistry, coagulation or urinalysis abnormalities, as assessed by the investigator, in Parts 1 and 2.
Measured: Baseline through 12 months after the last dose (up to approximately 20 months).
Secondary outcomes (7)
Maximum serum NOR-101 concentration (Cmax)
Maximum observed concentration in Part 1 and in Part 2.
Measured: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
Area under the NOR-101 serum concentration-time curve (AUC)
AUC from dosing to the last quantifiable concentration after single dosing, and over the dosing interval after repeated dosing, in Part 1. AUC following multiple dosing in Part 2.
Measured: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
NOR-101 terminal elimination half-life
Terminal half-life after single or repeated dosing in Part 1, where reliably estimable.
Measured: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
Incidence of anti-NOR-101 antibodies
Participants with anti-drug antibodies in Parts 1 and 2.
Measured: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
NOR-101 time to maximum serum concentration (Tmax)
Time to maximum observed serum concentration after single and repeated dosing in Part 1.
Measured: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
NOR-101 apparent clearance (CL/F)
Apparent serum clearance after single and repeated dosing in Part 1, where reliably estimable.
Measured: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
NOR-101 apparent volume of distribution (Vz/F)
Apparent volume of distribution during the terminal phase after single and repeated dosing in Part 1, where reliably estimable.
Measured: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1: randomized NOR-101 and placebo groups in sequential single-dose and multiple-dose cohorts. Part 2: two open-label NOR-101 cohorts.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Immunology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohit Gupta, MD, Study director, North Immunology Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904689
- Sponsor's protocol ID
- NOR-101-001
- Acronym
- POLARIS-1
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-Part, First-in-Human, Randomized, Blinded, Placebo-Controlled, Single and Multiple Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of NOR-101 in Healthy Participants and Participants With Moderate-to-Severe Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT07904689
- Acronym / sponsor ID
- POLARIS-1 / NOR-101-001
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- North Immunology Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 study will assess NOR-101, an investigational study drug, in two parts. Part 1 is a randomized, blinded study comparing single and multiple doses of NOR-101 with placebo in healthy adults. A placebo is a look-alike substance containing no active drug. Part 2 is an open-label, multiple-dose study in adults with moderate-to-severe atopic dermatitis (eczema). All participants in Part 2 will receive NOR-101.
Detailed description
POLARIS-1 (NOR-101-001) is a two-part, first-in-human study of NOR-101, an investigational study drug being developed for atopic dermatitis. Part 1 is a randomized, blinded, placebo-controlled, single-dose and multiple-dose study in healthy adults.
Part 2 is an open-label, multiple-dose study in adults with moderate-to-severe atopic dermatitis. The study evaluates safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Part 1: randomized NOR-101 and placebo groups in sequential single-dose and multiple-dose cohorts. Part 2: two open-label NOR-101 cohorts.
| Arm | Type | Receives |
|---|---|---|
| Part 1 SAD NOR-101 | Experimental | Drug: NOR-101Single dose of NOR-101 in healthy adults across planned and optional single-dose cohorts. |
| Part 1 SAD Placebo | Placebo comparator | Drug: PlaceboSingle dose of placebo in healthy adults across planned and optional single-dose cohorts. |
| Part 1 MD NOR-101 | Experimental | Drug: NOR-101Multiple doses of NOR-101 in healthy adults across planned and optional multiple-dose cohorts. |
| Part 1 MD Placebo | Placebo comparator | Drug: PlaceboMultiple doses of placebo in healthy adults across planned and optional multiple-dose cohorts. |
| Part 2 Cohort 1 NOR-101 | Experimental | Drug: NOR-101Multiple doses of NOR-101 in adults with moderate-to-severe atopic dermatitis (open-label). |
| Part 2 Cohort 2 NOR-101 | Experimental | Drug: NOR-101Multiple doses of NOR-101 in adults with moderate-to-severe atopic dermatitis (open-label) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All: written informed consent; able to follow procedures, follow-up and contraception rules.
- Part 1: healthy adults; BMI 18 to below 32 kg/m²; weight above 50 kg; suitable injection sites; able to complete confinement and blood sampling.
- Part 2: Atopic Dermatitis for at least 12 months with inadequate response to topical prescription therapy (or such therapy unsuitable); BMI 17.5 to below 35 kg/m²; weight above 50 and below 120 kg; stable emollient use for at least 7 days without substantial improvement; washouts completed.
Key exclusion criteria (4 listed)
- Clinically significant illness, infection, or laboratory or ECG abnormality; tuberculosis, helminth, HIV, hepatitis B or C (protocol exceptions apply).
- Exclusionary malignancy or lymphoproliferative disorder; hypersensitivity; injection intolerance.
- Recent prohibited treatments, investigational agents or live vaccines; pregnancy, breastfeeding or planned pregnancy; alcohol or drug misuse.
- Part 2: interfering skin disease or active skin infection; systemic JAK inhibitor exposure over one month or non-response.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOR-101NOR-101 will be administered | Drug | Part 1 MD NOR-101, Part 1 SAD NOR-101, Part 2 Cohort 1 NOR-101, Part 2 Cohort 2 NOR-101 |
| PlaceboPlacebo will be administered | Drug | Part 1 MD Placebo, Part 1 SAD Placebo |
Primary outcome
Number of participants with adverse events
Time frame: From informed consent through the end of the trial (EOT), up to approximately 29 months.
Number of participants with adverse events, including serious adverse events, summarized by severity and relationship to study intervention in Parts 1 and 2.
Number of participants with clinically significant vital sign abnormalities
Time frame: Baseline through 12 months after the last dose (up to approximately 20 months).
Number of participants with clinically significant vital sign abnormalities, as assessed by the investigator, in Parts 1 and 2.
Number of participants with clinically significant electrocardiogram abnormalities
Time frame: Baseline through 12 months after the last dose (up to approximately 20 months).
Number of participants with clinically significant abnormalities on 12-lead electrocardiograms, as assessed by the investigator, in Parts 1 and 2.
Number of participants with clinically significant clinical laboratory abnormalities
Time frame: Baseline through 12 months after the last dose (up to approximately 20 months).
Number of participants with clinically significant hematology, serum chemistry, coagulation or urinalysis abnormalities, as assessed by the investigator, in Parts 1 and 2.
7 secondary outcomes
Maximum serum NOR-101 concentration (Cmax)
Time frame: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
Area under the NOR-101 serum concentration-time curve (AUC)
Time frame: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
NOR-101 terminal elimination half-life
Time frame: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
Incidence of anti-NOR-101 antibodies
Time frame: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
NOR-101 time to maximum serum concentration (Tmax)
Time frame: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
NOR-101 apparent clearance (CL/F)
Time frame: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
NOR-101 apparent volume of distribution (Vz/F)
Time frame: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohit Gupta, MD study director
North Immunology Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NOR-101 in people with Atopic Dermatitis (AD), run by North Immunology Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramei Sani-Grosso (484-686-0505, ramei@northimmunology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: From informed consent through the end of the trial (EOT), up to approximately 29 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.