A Phase 1 interventional study of NOR-101 and Placebo in Atopic Dermatitis (AD), sponsored by North Immunology Inc.. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by North Immunology Inc. · Phase 1, Interventional, and Treatment
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.
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 96 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →This is the only study on the registry with North Immunology Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single dose of NOR-101 in healthy adults across planned and optional single-dose cohorts.
Drug: NOR-101
Single dose of placebo in healthy adults across planned and optional single-dose cohorts.
Drug: Placebo
Multiple doses of NOR-101 in healthy adults across planned and optional multiple-dose cohorts.
Drug: NOR-101
Multiple doses of placebo in healthy adults across planned and optional multiple-dose cohorts.
Drug: Placebo
Multiple doses of NOR-101 in adults with moderate-to-severe atopic dermatitis (open-label).
Drug: NOR-101
Multiple doses of NOR-101 in adults with moderate-to-severe atopic dermatitis (open-label)
Drug: NOR-101
NOR-101 will be administered
Placebo will be administered
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through 12 months after the last dose (up to approximately 20 months).
Maximum serum NOR-101 concentration (Cmax)
Maximum observed concentration in Part 1 and in Part 2.
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)
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.
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
Terminal half-life after single or repeated dosing in Part 1, where reliably estimable.
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
Participants with anti-drug antibodies in Parts 1 and 2.
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 to maximum observed serum concentration after single and repeated dosing in Part 1.
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)
Apparent serum clearance after single and repeated dosing in Part 1, where reliably estimable.
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)
Apparent volume of distribution during the terminal phase after single and repeated dosing in Part 1, where reliably estimable.
Time frame: First dose through up to approximately 20 months after the last dose (up to approximately 28 months).
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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