Testing the new drug NOR-101 in healthy adults and adults with eczema
Tests NOR-101 in healthy adults and in adults with atopic dermatitis.
Plain-language title generated from the registry record
Registry title: A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
Key facts
- Where
- Adelaide, AustraliaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults (Part 1) and adults with moderate-to-severe atopic dermatitis, also called eczema (Part 2), to test a new drug, NOR-101.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Part 2: atopic dermatitis for at least 12 months, moderate to severe. Cohort 1 needs EASI at least 16, vIGA-AD at least 3, body surface area at least 10%, weekly peak itch score at least 4. Cohort 2 needs EASI at least 12, vIGA-AD at least 2, body surface area at least 5%, weekly peak itch score at least 3.
- Earlier treatment
- Part 2: inadequate response to topical prescription therapy, or such therapy is unsuitable. Stable emollient use for at least 7 days without substantial improvement. Cohort 1: not exposed to dupilumab. Cohort 2: at least 16 weeks of prior dupilumab with inadequate response.
Main reasons for not taking part
- Clinically significant illness, infection, or lab or ECG abnormality
- Tuberculosis, helminth, HIV, hepatitis B or C (protocol exceptions apply)
- Pregnancy, breastfeeding or planned pregnancy
- Recent prohibited treatments, investigational agents or live vaccines
- Part 2: interfering skin disease or active skin infection
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07904689, who can take part
Where in Australia
- CMAX Clinical Research Pty LtdAdelaide, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- North Immunology Inc.
- Trial code
- NCT07904689
- Record updated
- 29 October 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Recent prohibited treatments, investigational agents or live vaccines; pregnancy, breastfeeding or planned pregnancy; alcohol or drug misuse; Exclusionary malignancy or lymphoproliferative disorder; hypersensitivity; injection intolerance; Part 2: interfering skin disease or active skin infection; systemic JAK inhibitor exposure over one month or non-response; Clinically significant illness, infection, or laboratory or ECG abnormality; tuberculosis, helminth, HIV, hepatitis B or C (protocol exceptions apply).