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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 45 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Voluntarily signed informed consent, and was able to communicate well with the investigator and can complete the study according to the study requirement. 2. 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. 3. No evidence of active or latent mycobacterium tuberculosis infection or the mycobacterium tuberculosis infection without regulated treatment. 4. 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.

Exclusion Criteria:

1. Unable to follow the study protocol requirements. 2. Evidence or history of clinically significant disease, or evidence or history of allergic disease. 3. Subjects with clinically significant gastrointestinal dysfunction that may affect drug intake, transport or absorption. 4. Acute disease state within 14 days before administration. 5. Currently or within 6 months prior to administration experiencing a severe infection or having a long-term or recurrent infection disease. 6. Subjects and/or first-degree relatives have a genetic immune deficiency. 7. Major trauma or surgery within 3 months prior to the first administration. 8. Had a history of tuberculosis or active/latent infection, or received systemic anti-infection therapy within 14 days prior to enrollment. 9. Urine drug test positive. 10. Alcoholic. 11. Subjects who have used tobacco/cigarettes or tobacco/cigarette products within 3 months prior to the first administration. 12. 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. 13. 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). 14. Consume any food or drink containing caffeine within 48 hours prior your first administration. 15. Subject who receive the drugs or foods known to have CYP3A4 inhibitory or inducing the effects within 2 weeks prior to initial administration or plan to received during the study period. 16. Diet or dietary treatment within 30 days prior to initial administration or have significant change in eating habits. 17. Eat smoked charcoal fire foods (such as Carbon barbecue,etc) within 1 week prior to the study. 18. The physical and laboratory results did not meet the requirements of the clinical trial protocol. 19. Received vaccination with live virus vaccine, live attenuated vaccine or any live virus component is administered within 6 weeks prior to initial administration, or during the planned study period or within 8 weeks after the end of the study. 20. Other situations judged by the investigator to be unsuitable to join this trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05451199
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Beijing InnoCare Pharma Tech Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Qianjin Lu
Principal Investigator Affiliation Hospital for Skin Diseases, Chinese Academy of medical Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Arms & Interventions

Arms

Experimental: ICP-488

Single ascending doses of ICP-488 tablet; Multiple ascending doses of ICP-488 tablet;

Placebo Comparator: Placebo

Single ascending doses of placebo; Multiple ascending doses of placebo

Interventions

Drug: - ICP-488

ICP-488 will be administered as tablet

Drug: - Placebo

Matching placebo will be administered as tablet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nanjing, Jiangsu, China

Status

Recruiting

Address

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

Nanjing, Jiangsu, 210000

Site Contact

Qianjin Lu

[email protected]

+86 18233150939

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