A Clinical Study of ICP-488 in Healthy Subjects and Patients With Psoriasis

NCT05451199 | Unknown Phase 1

• 1 other identifier: ICP-CL-01001
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 7

Brief Summary

This is a Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single and Multiple AscendingDose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-488 in Healthy Subjects and Patients With Psoriasis

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events during treatment, and withdrawal from treatment due to adverse events

  Single ascending dose: 1day；Multiple ascending dose: 28 days

Secondary Outcomes (6)

• Cmax

  Single ascending dose: 1day；Multiple ascending dose: 28 days

• Psoriasis Area and Severity Index （PASI）

  Day1,Day7,Day14,Day21,Day28,Day35,Day42,Day56

• Body Surface Area （BSA）

  Day1,Day7,Day14,Day21,Day28,Day35,Day42,Day56

• Static Physician's Global Assessment （sPGA）

  Day1,Day7,Day14,Day21,Day28,Day35,Day42,Day56

• Peak Pruritus Numerical Rating Scale （PP-NRS）

  Day1-Day14, Day21, Day28, Day35, Day42, Day56

Study Arms (2)

ICP-488

EXPERIMENTAL

Single ascending doses of ICP-488 tablet; Multiple ascending doses of ICP-488 tablet; Part3 Patients with Psoriasis:ICP-488 tablet.

Drug: ICP-488

Placebo

PLACEBO COMPARATOR

Single ascending doses of placebo; Multiple ascending doses of placebo; Part3 Patients with Psoriasis of placebo.

Drug: Placebo

Interventions

ICP-488 DRUG

ICP-488 will be administered as tablet

ICP-488

Placebo DRUG

Matching placebo will be administered as tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed informed consent, and was able to communicate well with the investigator and can complete the study according to the study requirement.
• Body mass index (BMI) between 18-26 kg/m2, the weight of male subject should not be less than 50 kg, and the weight of female subject should not be less than 45 kg.
• The results of laboratory tests during the screening period are within the normal reference values of the population or study site;Or the results were slightly off but within acceptable limits, and the investigator evaluated that they were not clinically significant.
• Fertility status: Female subjects who are infertile (i.e. physically unable to conceive, including postmenopausal or surgically infertile women);Male subjects and their partners must agree to use effective contraception for the entire study period and for 28 days after the last medication or for five half-lives, and male subjects shall not donate sperm during this period.
• Male or female subjects aged ≥ 18 years and ≤ 65 years；
• Diagnosis of plaque psoriasis；
• All of the following 3 criteria are met at screening and randomization:
• ）Psoriasis Area and Severity Index (PASI) ≥ 12; 2）Physician Global Assessment (PGA) ≥ 3; 3）Body surface area (BSA) affected by psoriasis ≥ 10%.
• \. The subject is a candidate to receive systemic therapy and/or phototherapy.

You may not qualify if:

• Unable to follow the study protocol requirements.
• Evidence or history of clinically significant disease, or evidence or history of allergic disease.
• Subjects with clinically significant gastrointestinal dysfunction that may affect drug intake, transport or absorption.
• Acute disease state within 14 days before administration.
• Currently or within 6 months prior to administration experiencing a severe infection or having a long-term or recurrent infection disease
• Subjects and/or first-degree relatives have a genetic immune deficiency.
• Major trauma or surgery within 3 months prior to the first administration.
• Previous medical history of tuberculosis; The presence of investigator-judged signs or symptoms of active tuberculosis and the chest imaging showed active pulmonary tuberculosis at screening ；T-spoT test (T-SPOT) was positive at screening.
• Urine drug test positive.
• Alcoholic
• Subjects who have used tobacco/cigarettes or tobacco/cigarette products within 3 months prior to the first administration.
• Subjects who donated more than 500 ml of blood (excluding plasma) within 56 days before the first dose, or planned to donate blood or blood components during the study period or within 1 month after the study finished.
• Use of any other study drug specified in the protocol within 30 days prior to initial administration or within 5 half-lives(refer to whichever is longer).
• Any traditional Chinese medicine (TCM) and over-the-counter (OTC) drugs, vitamins, systemic steroid hormone therapy, immunosuppressant or modulator therapy, hormone replacement therapy, and other food supplements or herbs were used 30 days before the first dose until follow-up visit.
• Consume any food or drink containing caffeine within 48 hours prior your first administration.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (7)

The Second Hospital of Anhui Meidcal University

Hefei, Anhui, 230601, China

NOT YET RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

NOT YET RECRUITING

Nanyang First People's Hospital

Nanyang, Henan, 473004, China

NOT YET RECRUITING

Shiyan Renmin Hospital

Shiyan, Hubei, 442000, China

RECRUITING

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of medical Sciences, Peking Union Medical College

Nanjing, Jiangsu, 210000, China

RECRUITING

Yanbian University Hospital

Yanji, Jilin, 133000, China

NOT YET RECRUITING

Hangzhou First People's Hospital

Hangzhou, Zheajing, 310006, China

NOT YET RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Qianjin Lu

  Hospital for Skin Diseases, Chinese Academy of medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Zhao

CONTACT

+86 18233150939; Lisa.zhao@innocarepharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 11, 2022
• Study Start: July 29, 2022
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (7)