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HS-2018의 안전성 및 약동학/약력학을 평가하십시오

2026년 11월 2일 업데이트: Jiangsu Hansoh Pharmaceutical Co., Ltd.

성인 참가자에서 HS-2018의 단일 및 다중 상승 용량의 안전성, 내약성, 면역 원성, 약동학 및 약력학을 평가하기위한 I 상 임상 연구

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 .

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

60

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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;

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 순차적 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: HS-20118

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

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

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

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Cmax
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Jiangsu Hansoh Pharmaceutical Co., Ltd.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 5월 2일

기본 완료 (실제)

2026년 7월 14일

연구 완료 (실제)

2026년 7월 14일

연구 등록 날짜

최초 제출

2025년 2월 12일

QC 기준을 충족하는 최초 제출

2025년 2월 20일

처음 게시됨 (실제)

2025년 2월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • HS-20118-101

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다