Study of HXN6005 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis
19 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
67
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Tong Gang
- Numero di telefono: (86)13918569690
- Email: tonggang@helixon.com
Luoghi di studio
-
-
Zhejiang
-
Hangzhou, Zhejiang, Cina, 310006
- Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
-
Contatto:
- Liming Wu
- Email: 18957118053@163.com
-
Contatto:
- Ying Wang
- Email: nancywangying@163.com
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
Inclusion Criteria:
- Participants must be able to understand and comply with the study requirements and voluntarily sign the informed consent form (ICF).
- (Healthy Participants) Male or female participants aged 18 to 55 years (inclusive) at the time of signing the ICF.
- (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).
- (Patients with AD) Male or female participants aged 18 to 70 years (inclusive) .
- (Patients with AD) Participants must have documented AD history, moderate-to-severe disease, and inadequate response to topical therapy at screening.
Exclusion Criteria:
- Presence of any clinically significant disease at randomization, as judged by the investigator.
- Known or suspected allergy or intolerance to any component or excipient of HXN6005 injection or placebo.
- History of severe drug allergy or systemic anaphylactic reactions, such as anaphylactic shock, laryngeal edema, etc.
- 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.
- 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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Part A Single Ascending Dose (SAD)
Participants will receive a single subcutaneous dose of HXN6005
|
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
|
|
Comparatore placebo: Part A Placebo (SAD)
Participants will receive a single subcutaneous dose of placebo
|
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
Participants will be enrolled in a single cohort and will receive multiple subcutaneous doses of placebo.
|
|
Sperimentale: Part B Multiple Ascending Dose (MAD)
Participants will receive multiple subcutaneous doses of HXN6005
|
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
|
|
Comparatore placebo: Part B Placebo (MAD)
Participants will receive multiple subcutaneous doses of placebo
|
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
Participants will be enrolled in a single cohort and will receive multiple subcutaneous doses of placebo.
|
|
Sperimentale: Part C Multiple Dose efficacy exploration
Participants will receive multiple subcutaneous doses of HXN6005
|
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
|
|
Comparatore placebo: Part C Multiple Dose placebo-controlled
Participants will receive multiple subcutaneous doses of placebo
|
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
Participants will be enrolled in a single cohort and will receive multiple subcutaneous doses of placebo.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Part A Adverse events
Lasso di tempo: Up to day 141
|
Incidence, severity, and causal relationship of Adverse Events (AEs)
|
Up to day 141
|
|
Part B Adverse Events
Lasso di tempo: Up to day 197
|
Incidence, severity, and causal relationship of Adverse Events (AEs)
|
Up to day 197
|
|
Part C Efficacy
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Up to day 197
|
The incidence of treatment-emergent ADA against HXN6005 was assessed in serum samples
|
Up to day 197
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
1 ottobre 2027
Completamento dello studio (Stimato)
1 gennaio 2028
Date di iscrizione allo studio
Primo inviato
13 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
19 agosto 2026
Primo Inserito (Effettivo)
24 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
19 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie genetiche, congenite
- Malattie del sistema immunitario
- Ipersensibilità, immediata
- Ipersensibilità
- Malattie della pelle
- Malattie della pelle, genetiche
- Malattie della pelle, eczematose
- Dermatite
- Malattie e anomalie congenite, ereditarie e neonatali
- Malattie della pelle e del tessuto connettivo
- Dermatite, atopica
Altri numeri di identificazione dello studio
- HXN6005-A1-201
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .