New eczema drug candidate tested in healthy chinese volunteers
NCT ID NCT06214481
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a single dose of the experimental drug rocatinlimab in 20 healthy Chinese adults. The main goal was to see how the drug moves through the body and whether it is safe. This is a first step toward possibly using the drug to treat atopic dermatitis (eczema) in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rocatinlimab (AMG 451)
- What this could lead to
- If successful, this study could provide dosing and safety data needed to test rocatinlimab as a potential treatment for atopic dermatitis in Chinese patients.
- What could go wrong
- This is an early, small study in only 20 healthy people, not patients. It is designed to measure drug levels and safety, not to test if it works for the disease. Side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Jan 2024
- Finished
-
Jun 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must be a resident in mainland China, and of Chinese ancestry (participants whose parents within 3 generations are of Chinese ancestry). * Healthy male or female participants, between 18 and 65 years of age (inclusive) at the time of screening. * Body mass index between 18 and 30 kg/m\^2 (inclusive) at the time of screening and check-in. * Provide signed informed consent. Exclusion Criteria: * History or evidence, at screening or check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. * Evidence of any active bacterial, viral, or fungal infection at screening including but not limited to upper or lower respiratory tract infection, conjunctivitis, acute otitis media, gastritis, enteritis, skin infections, infections requiring treatment with systemic therapy (antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals) for which therapy has not been completed within 4 weeks before enrollment. * Immunocompromised participants at risk for viral reactivation including participants with history of solid organ transplantation, hematopoietic stem cell transplantation, or cellular therapy. * Participants with disrupted skin integrity (apparent burn or dermatitis). * Prior history of autoimmune disease including but not limited to inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), lupus, rheumatoid arthritis, psoriasis/psoriatic arthritis, multiple sclerosis. * Positive hepatitis B surface antigen (HBsAg)/hepatitis B core antibody (HBcAb) or hepatitis C virus antibody and/or positive human immunodeficiency virus test, at screening. Participants whose hepatitis B and C results are compatible with prior immunity (resulting from inoculation) may be included. * Positive T-spot test at screening. * Participants who have received live vaccines within 5 weeks prior to screening, or plan to receive live vaccines within 120 days after administration of an investigational product. * Participants who have received coronavirus disease 2019 vaccine within 30 days prior to check-in, or plan to receive a coronavirus disease 2019 vaccine within 120 days post-dose. * Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in. 1. Acetaminophen (paracetamol; up to 2 g/day) for analgesia will be allowed. 2. Hormone replacement therapy (e.g., estrogen) and hormonal contraceptives will be allowed. * Participant has received a dose of an investigational drug within the past 90 days or 5 half-lives, whichever is longer, prior to check-in. * Have previously completed or withdrawn from this study or any other study investigating rocatinlimab or have previously received the investigational product.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Huashan Hospital Affiliated to Fudan University?
Shanghai, 200040, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Skin scans may predict who responds to dupilumab for eczema
- Can a daily liquid medicine calm severe eczema in toddlers and preschoolers?
- Scientists probe whether lebrikizumab rewires diseased skin at the molecular level
- Can a Lab-Made antibody calm severe eczema?
- Is your nose fueling infected eczema and scabies sores?
- Can an eczema drug reshape the Skin's microbial community?