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Évaluer la sécurité et la pharmacocinétique / pharmacodynamique de HS-20188

2 novembre 2026 mis à jour par: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Une étude clinique de phase I pour évaluer la sécurité, la tolérabilité, l'immunogénicité, la pharmacocinétique et la pharmacodynamique des doses ascendantes uniques et multiples de HS-2018 chez les participants adultes

The study will be conducted in 2 parts (SAD for Part 1 and MAD for Part2). Part 1 is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of HS-20118 after a single oral dose in healthy participants.

Part 2 is a multi-center, randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability, immunogenicity, PK, and PD of HS-20118 after multiple oral doses in patients with moderate to severe plaque psoriasis .

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The study will be conducted in 2 parts (SAD for Part 1 and MAD for Part2). Part 1 is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of HS-20118 after a single oral dose in healthy participants.

Part 1 will consist of 5 cohorts, i.e., X1 mg, X2 mg, X3 mg, X4 mg, and X5 mg dose cohorts (each cohort will include 3 participants to receive placebo). There will be no restriction on the male-to-female ratio. Each cohort will include 12 participants (HS-20118:placebo = 9:3), with a total of 60 participants. Participants will undergo PK blood sampling, ADA blood sampling, PD blood sampling and safety examinations during the study.

Part 2 is a multi-center, randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability, immunogenicity, PK, and PD of HS-20118 after multiple oral doses in patients with moderate to severe plaque psoriasis.

Part 2 will tentatively consist of 6 cohorts ( HS-20118 vs placebo = 9:3), i.e., (1) A1 mg, (2) A2 mg, (3) A3 mg, (4) A4 mg, (5) A5 mg, (6) A6 mg. Each cohort will include 12 participants (HS-20118:placebo = 9:3), with a total of 72 participants. There will be no restriction on the male-to-female ratio. Participants will undergo PK blood sampling, ADA blood sampling, PD blood sampling and safety examinations during the study.

Type d'étude

Interventionnel

Inscription (Réel)

60

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Nouvelle-Zélande
    • Auckland
      • Takapuna, Auckland, Nouvelle-Zélande, 0622
        • Pacific Clinical Research Network (PCRN), Auckland
    • Christchurch
      • Christchurch, Christchurch, Nouvelle-Zélande, 8013
        • Pacific Clinical Research Network (PCRN), Christchurch
    • Dunedin
      • Dunedin, Dunedin, Nouvelle-Zélande, 9016
        • Momentum Clinical Research, Dunedin
    • Pukekohe
      • Pukekohe, Pukekohe, Nouvelle-Zélande, 2120
        • Momentum Clinical Research, Pukekohe
    • Upper Hutt
      • Upper Hutt, Upper Hutt, Nouvelle-Zélande, 5018
        • Pacific Clinical Research Network (PCRN), Wellington
    • Wellington Region
      • Mount Cook, Wellington Region, Nouvelle-Zélande, 6021
        • Momentum Clinical Research, Wellington
  • États-Unis
    • California
      • Anaheim, California, États-Unis, 92806
        • Kinetic Clinical Research
    • Florida
      • Miami Lakes, Florida, États-Unis, 33016
        • Clinitiative - Floridian Clinical Research, LLC
      • Pompano Beach, Florida, États-Unis, 33060
        • NuLine Clinical Trial Center (Network)

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

For the SAD study:

  1. Healthy adults aged 18-45 years (inclusive) at the time of signing the informed consent form;
  2. Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg; body mass index (weight/square of height (kg/m2)) within the range of 18-28 kg/m2 (inclusive);
  3. Normal results or abnormal results but without clinical significance in comprehensive examinations, including general physical examination, vital signs, laboratory tests, 12-lead ECG, abdominal color Doppler ultrasound, and chest X-ray from the frontal and lateral position ;

For the MAD study:

  1. Male or female participants aged 18-65 years (inclusive) at the time of signing the informed consent form;
  2. Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg;
  3. Chronic plaque psoriasis for at least 6 months with or without psoriatic arthritis;

Exclusion Criteria:

For the SAD study:

  1. Participants with immune-related diseases and medical history at screening;
  2. Participants with a history of drug or other allergies who are considered by the investigator to be at high risk for participating in this study, or who may be allergic to the investigational medicinal product or any component of the investigational medicinal product as judged by the investigator;
  3. History of drug abuse within the past 5 years or use of illicit drugs within 3 months before the study; or positive for urine drug screening;

For the MAD study:

  1. Guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced psoriasis, or other diseases that affect the treatment results;
  2. Current use of illicit drugs or prior use of illicit drugs within the specific time periods;
  3. Known history of recurrent or chronic infections, or prior history of chronic or recurrent infections, including but not limited to: chronic renal infection, chronic chest infection (e.g., bronchiectasis), symptomatic urinary tract infection, and open, draining, or infected skin wounds; history of serious infections (e.g., sepsis, pneumonia, and pyelonephritis), or hospitalization or treatment with intravenous antibiotics for infections within 2 months before screening;

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: HS-20118

Single and multiple ascending doses of HS-20118 orally
Médicament: HS-20118

Single and multiple ascending doses of HS-20118 orally
Comparateur placebo: placebo

Single and multiple ascending doses of HS-20118-matched placebo orally
Autre: HS-20118 placebo

Single and multiple ascending doses of HS-20118-matched placebo orally

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Number of participants with abnormalities of physical examination
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Physical examination includes skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, and spine/limbs, etc.
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Number of participants with abnormalities of vital signs
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Vital sign measured include body temperature, blood pressure, pulse, and respiratory rate.
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Number of participants with clinical laboratory abnormalities
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Clinical laboratory tests include blood biochemistry test, hematology test, urinalysis, coagulation function test, etc.
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Number of participants with abnormalities of electrocardiogram (ECG) parameters
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Cmax
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Maximum plasma concentration
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Tmax
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Time to reach Cmax
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
AUC
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Area under the plasma concentration-time curve
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
t½
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Terminal half-life
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
CL/F
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Apparent clearance
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Vd/F
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Apparent volume of distribution
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Rac
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Accumulation ratio
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Incidence of Anti-drug antibody (ADA)
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Anti-drug antibody (ADA)
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of psoriasis area and severity index (PASI) 75
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of psoriasis area and severity index (PASI) 90
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of psoriasis area and severity index (PASI) 100
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of Investigator's Global Assessment (IGA) 0/1
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The investigator scores each of infiltration/hypertrophy (I), erythema (E), and scaling (S) as a whole
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of Investigator's Global Assessment (IGA) 0
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The investigator scores each of infiltration/hypertrophy (I), erythema (E), and scaling (S) as a whole
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Change from baseline in psoriasis area and severity index (PASI) total score
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Change from baseline in body surface area (BSA)
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The total BSA affected by plaque psoriasis is estimated based on the percent area affected, including head, trunk, upper extremities, and lower extremities
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Change from baseline in dermatology life quality index (DLQI)
Délai: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne, and viral warts
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 mai 2025

Achèvement primaire (Réel)

14 juillet 2026

Achèvement de l'étude (Réel)

14 juillet 2026

Dates d'inscription aux études

Première soumission

12 février 2025

Première soumission répondant aux critères de contrôle qualité

20 février 2025

Première publication (Réel)

26 février 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HS-20118-101

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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