Study of HXN6005 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Tong Gang
- Telefonnummer: (86)13918569690
- E-post: tonggang@helixon.com
Studiesteder
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310006
- Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
-
Ta kontakt med:
- Liming Wu
- E-post: 18957118053@163.com
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Ta kontakt med:
- Ying Wang
- E-post: nancywangying@163.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Placebo komparator: 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.
|
|
Eksperimentell: 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.
|
|
Placebo komparator: 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.
|
|
Eksperimentell: 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.
|
|
Placebo komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Part A Adverse events
Tidsramme: Up to day 141
|
Incidence, severity, and causal relationship of Adverse Events (AEs)
|
Up to day 141
|
|
Part B Adverse Events
Tidsramme: Up to day 197
|
Incidence, severity, and causal relationship of Adverse Events (AEs)
|
Up to day 197
|
|
Part C Efficacy
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Up to day 197
|
The incidence of treatment-emergent ADA against HXN6005 was assessed in serum samples
|
Up to day 197
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HXN6005-A1-201
Plan for individuelle deltakerdata (IPD)
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