Phase 1 Eczema Trial, Recruiting NCT07488065 Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Condition: Eczema
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Phase 1 Eczema Trial, Recruiting

NCT07488065
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:

For the healthy volunteer part of the trial (Phase Ia):

  • People who are able to understand the study requirements and are willing to sign a consent form agreeing to take part.
  • People aged 18 to 55 years (any gender).
  • Men who weigh at least 50 kg and women who weigh at least 45 kg, with a body mass index (a measure of body weight relative to height) between 18.0 and 28.0.
  • People with no significant health problems identified by the trial doctors.

For the eczema part of the trial (Phase Ib):

  • People who are able to understand the study requirements and are willing to sign a consent form agreeing to take part.
  • People aged 18 to 70 years (any gender).
  • People who weigh at least 45 kg.
  • People who have had a confirmed diagnosis of moderate to severe atopic dermatitis (eczema) for at least one year, where the condition affects at least 10% of the body surface, and where specific severity scores measured at screening and at the start of the trial meet the required thresholds (confirm with trial site).
  • People who have previously tried at least 4 weeks of strong steroid creams, 2 weeks of very strong steroid creams or tablets, or creams that calm the immune response (calcineurin inhibitors), before entering the screening period.

Who may not be able to join:

  • People with a history of significant heart, blood, liver, kidney, digestive, nerve, breathing, or mental health conditions, or metabolic disorders that could affect the trial results.
  • People with any history of cancer, whether treated or untreated.
  • People who have skin scarring, swelling, infection, ulcers, bleeding, or other skin problems at the area where injections would be given.
  • People who have had signs of an active infection in the 4 weeks before joining the trial, such as urinary, lung, sinus, or blood infections.
  • People with a history of tuberculosis, or whose chest scans or blood tests show results of concern related to tuberculosis.
  • People who test positive for Hepatitis B, Hepatitis C, HIV, or syphilis.

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: 86-028-67255165

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
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
31 March 2026
Est. completion
31 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Number of participants with adverse events (AEs) /TEAEs; Proportion of participants achieving EASI-75 at Week 16

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