Phase 1 Eczema Trial, Recruiting NCT06082323 Sponsor: Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. Condition: Eczema
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Phase 1 Eczema Trial, Recruiting

NCT06082323
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:

  • People who fully understand what the study involves, including its processes and possible side effects, and are able to sign a written consent form.
  • People aged 18 to 55 years old (inclusive) at the time of signing the consent form.
  • People with a body mass index (BMI) between 18 and 30 kg/m² (inclusive), and a body weight of at least 50 kg for men or at least 45 kg for women.
  • People who test negative for SARS-CoV-2 (the virus that causes COVID-19) on the day of admission to the study.
  • People who are in good general health, with no significant medical history, as confirmed by a doctor through physical examination, heart tracing (ECG), and various blood and urine tests.
  • Women who are not pregnant or breastfeeding, and who test negative on a pregnancy test at the screening visit. Both men and women of reproductive age must be willing to use highly effective contraception from the start of the study until 6 months after the last dose, and must also be willing to avoid donating sperm or eggs during the study and for 6 months after the last dose.
  • People who are willing and able to attend all scheduled visits and follow all study procedures as required.

Who may not be able to join:

  • People with a history of significant allergies, including severe allergic reactions (anaphylaxis) to food or medicines, or who may be allergic to any ingredient in the study drug.
  • People who follow a vegan diet or who have medically required dietary restrictions.
  • People with a clinically significant history of conditions affecting the lungs, immune system, skin, heart, liver, kidneys, blood, nervous system, digestive system, muscles or joints, urinary system, hormones, or mental health — as assessed by the study doctor.
  • People who have stomach or digestive symptoms at the time of screening or admission, such as nausea, vomiting, diarrhoea, or heartburn.
  • People who have an active infection, such as the flu, at the time of screening or admission.
  • People who have a higher risk of infection, including those who:
    • Have a history of tuberculosis, or test positive for a tuberculosis screening test (IGRA/QuantiFERON TB-Gold); or who have lived in or plan to visit areas where tuberculosis or certain fungal infections are common within 90 days before or during the study.
    • Engage in high-risk sexual practices (confirm with trial site).
    • Have had a cancer diagnosis in the past 5 years, other than a specific superficial skin cancer called basal cell carcinoma.
    • Have a history suggesting problems with immune system function.

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 28 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

Principal Investigator: Qian Chen, MD, Shanghai Xuhui Central Hospital

Phone: +86-012-54036058

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
Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
Registry
ClinicalTrials.gov
Start date
13 June 2024
Est. completion
31 March 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

To evaluate the safety and tolerability of LT-002-158 following single dose in HVs

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: 28 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