NCT07904689Not yet recruitingPhase 1
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
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.
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 23 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Jan 2030
- Lead sponsor
- North Immunology Inc.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07904689
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 96
- From 1 Nov 2026 to the primary completion date, 31 Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent prohibited treatments, investigational agents or live vaccines; pregnancy, breastfeeding or planned pregnancy; alcohol or drug misuse.
Other illness
- 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.
Lab values
- Clinically significant illness, infection, or laboratory or ECG abnormality; tuberculosis, helminth, HIV, hepatitis B or C (protocol exceptions apply).
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CMAX Clinical Research Pty Ltd Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.