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
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?
Trial 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).