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Study of HXN6005 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis

2026年8月19日 更新者：Helixon Biotechnology (Suzhou) Co., Ltd

A Phase I/II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HXN6005 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis

This is a Phase I/II, multicenter, randomized, double-blind, placebo-controlled study evaluating HXN6005 in healthy participants and patients with moderate-to-severe atopic dermatitis (AD).

The study consists of three parts: Part A (single ascending dose in healthy participants), Part B (multiple ascending dose in AD patients), and Part C (multiple-dose efficacy and safety assessment in AD patients).

The primary objectives are to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of HXN6005.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Part A (Single Ascending Dose, SAD) is a randomized, double-blind, placebo-controlled, single-dose escalation design conducted in healthy participants. It includes two sequential dose cohorts. A total of 16 healthy participants are planned, with 8 participants per cohort (6 receiving HXN6005 and 2 receiving placebo). Participants receive a single subcutaneous injection of HXN6005 or placebo. All participants are followed for safety, PK, PD, and anti-drug antibody (ADA) assessments.

Part B (Multiple Ascending Dose, MAD) is a randomized, double-blind, placebo-controlled study conducted in patients with moderate-to-severe AD. Part B enrolls 16 patients across two dose cohorts, with 8 patients per cohort (6 receiving HXN6005 and 2 receiving placebo). Patients receive multiple subcutaneous injections of HXN6005 or placebo according to the study schedule.

Part C is a multicenter, randomized, double-blind, placebo-controlled study conducted in patients with moderate-to-severe AD. A total of 35 patients are planned to be randomized into two HXN6005 dose groups and one placebo group, receiving multiple subcutaneous doses according to the study schedule. Regular follow-up visits are conducted to collect efficacy data, safety data, and blood samples for assessment of systemic exposure, immunogenicity, and biomarkers.

研究の種類

介入

入学 (推定)

67

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310006
        • Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
        • コンタクト：
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

  1. Participants must be able to understand and comply with the study requirements and voluntarily sign the informed consent form (ICF).
  2. (Healthy Participants) Male or female participants aged 18 to 55 years (inclusive) at the time of signing the ICF.
  3. (Healthy Participants) Male participants weighing ≥ 50.0 kg and female participants weighing ≥ 45.0 kg, with a body mass index (BMI) between 18.0 and 28.0 kg/m² (inclusive).
  4. (Patients with AD) Male or female participants aged 18 to 70 years (inclusive) .
  5. (Patients with AD) Participants must have documented AD history, moderate-to-severe disease, and inadequate response to topical therapy at screening.

Exclusion Criteria:

  1. Presence of any clinically significant disease at randomization, as judged by the investigator.
  2. Known or suspected allergy or intolerance to any component or excipient of HXN6005 injection or placebo.
  3. History of severe drug allergy or systemic anaphylactic reactions, such as anaphylactic shock, laryngeal edema, etc.
  4. Known or suspected history of immunosuppression, or history of invasive opportunistic infections, including infections that are unusually frequent, recurrent, or prolonged in duration as judged by the investigator, even after resolution of the infection.
  5. History of malignancy or malignant disease, with the exception of surgically excised cutaneous squamous cell carcinoma in situ, basal cell carcinoma, and cervical carcinoma in situ that have been in complete remission for more than 5 years without any evidence of recurrence.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Part A Single Ascending Dose (SAD)
Participants will receive a single subcutaneous dose of HXN6005
薬：HXN6005
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
薬：HXN6005
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
薬：HXN6005
Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
プラセボコンパレーター：Part A Placebo (SAD)
Participants will receive a single subcutaneous dose of placebo
薬：Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
薬：Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
薬：Placebo
Participants will be enrolled in a single cohort and will receive multiple subcutaneous doses of placebo.
実験的：Part B Multiple Ascending Dose (MAD)
Participants will receive multiple subcutaneous doses of HXN6005
薬：HXN6005
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
薬：HXN6005
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
薬：HXN6005
Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
プラセボコンパレーター：Part B Placebo (MAD)
Participants will receive multiple subcutaneous doses of placebo
薬：Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
薬：Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
薬：Placebo
Participants will be enrolled in a single cohort and will receive multiple subcutaneous doses of placebo.
実験的：Part C Multiple Dose efficacy exploration
Participants will receive multiple subcutaneous doses of HXN6005
薬：HXN6005
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
薬：HXN6005
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
薬：HXN6005
Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
プラセボコンパレーター：Part C Multiple Dose placebo-controlled
Participants will receive multiple subcutaneous doses of placebo
薬：Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
薬：Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
薬：Placebo
Participants will be enrolled in a single cohort and will receive multiple subcutaneous doses of placebo.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Part A Adverse events
時間枠：Up to day 141
Incidence, severity, and causal relationship of Adverse Events (AEs)
Up to day 141
Part B Adverse Events
時間枠：Up to day 197
Incidence, severity, and causal relationship of Adverse Events (AEs)
Up to day 197
Part C Efficacy
時間枠：Up to day 113
Change from baseline to Week 16 in the Eczema Area and Severity Index (EASI; range 0-72; higher scores indicate more severe disease) total score among AD participants
Up to day 113

二次結果の測定

結果測定
メジャーの説明
時間枠
Maximum Observed Plasma Concentration (Cmax)
時間枠：Up to day 197
The maximum (peak) observed drug concentration in plasma after administration
Up to day 197
Area Under the Plasma Concentration-Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t)
時間枠：Up to day 197
Area under the plasma concentration-time curve from time 0 (pre-dose) to the time of the last measurable (quantifiable) plasma concentration
Up to day 197
Incidence of antidrug antibodies (ADA) against HXN6005
時間枠：Up to day 197
The incidence of treatment-emergent ADA against HXN6005 was assessed in serum samples
Up to day 197

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Helixon Biotechnology (Suzhou) Co., Ltd

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年10月1日

研究の完了 (推定)

2028年1月1日

試験登録日

最初に提出

2026年8月13日

QC基準を満たした最初の提出物

2026年8月19日

最初の投稿 (実際)

2026年8月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月24日

QC基準を満たした最後の更新が送信されました

2026年8月19日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • HXN6005-A1-201

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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