Phase 1 Eczema Trial, Recruiting NCT07235384 Sponsor: Zai Lab (Shanghai) Co., Ltd. Condition: Eczema
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Phase 1 Eczema Trial, Recruiting

NCT07235384
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Part A (Healthy Volunteers):

  • People who are healthy male or female volunteers between 18 and 65 years old
  • People whose body weight falls within a moderate range (BMI of 18.5 to less than 32.5)
  • Women who could become pregnant must have a negative pregnancy test

Part B (Atopic Dermatitis Patients):

  • People between 18 and 65 years old
  • People whose body weight falls within a moderate range (BMI of 18.5 to less than 40.0)
  • People who have been diagnosed with atopic dermatitis (eczema) for at least 12 months before the study start date
  • People with moderate-to-severe atopic dermatitis, measured by specific scoring tools used by doctors at screening (confirm with trial site)
  • People whose eczema covers 10% or more of their body surface area
  • People who have not responded well enough to creams, ointments, or other skin-applied treatments in the past
  • People who have been experiencing significant itching (a score of 4 or more out of 10 on average) in the 7 days before being enrolled
  • Women who could become pregnant must have a negative pregnancy test

Who may not be able to join:

Parts A and B:

  • People who test positive for HIV, hepatitis B, hepatitis C, or active tuberculosis, or who have immune system disorders or autoimmune diseases
  • People with a significant history of metabolic, liver, kidney, or blood disorders
  • People with abnormal heart rhythm or electrical activity findings on a heart tracing (ECG)
  • People with abnormal blood test results, including low blood cell counts or signs of liver or kidney problems
  • People with a history of drug abuse or addiction in the 6 months before screening
  • People who currently smoke or have used any tobacco or nicotine products in the 6 months before dosing
  • People who have donated more than 500mL of blood within 2 months of the dosing date

Part B only:

  • People who have other skin conditions that could make it difficult to assess atopic dermatitis accurately
  • People with an uncontrolled long-term illness that may require courses of oral steroid tablets
  • People whom the trial investigator determines should not participate for medical, psychiatric, or social reasons (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +86 021-61632588

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Zai Lab (Shanghai) Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 December 2025
Est. completion
28 December 2027

Where this trial is recruiting

🇳🇿 New Zealand

Primary endpoints

Number of participants with adverse events (AEs); Number of participants with serious adverse events (SAEs); Number of participants with clinical laboratory abnormalities; Number of participants with vital sign abnormalities; Number of participants with electrocardiogram (ECG) abnormalities

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov