A Clinical Study of ICP-488 in Healthy Subjects and Patients With Psoriasis
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ICP-488 Single ascending doses of ICP-488 tablet; Multiple ascending doses of ICP-488 tablet; |
Drug: ICP-488
ICP-488 will be administered as tablet
|
| Placebo Comparator: Placebo Single ascending doses of placebo; Multiple ascending doses of placebo |
Drug: Placebo
Matching placebo will be administered as tablet
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Cmax [Single ascending dose: 1day；Multiple ascending dose: 28 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
-
No evidence of active or latent mycobacterium tuberculosis infection or the mycobacterium tuberculosis infection without regulated treatment.
-
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:
-
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.
-
Had a history of tuberculosis or active/latent infection, or received systemic anti-infection therapy within 14 days prior to enrollment.
-
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).
-
Consume any food or drink containing caffeine within 48 hours prior your first administration.
-
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.
-
Diet or dietary treatment within 30 days prior to initial administration or have significant change in eating habits.
-
Eat smoked charcoal fire foods (such as Carbon barbecue,etc) within 1 week prior to the study.
-
The physical and laboratory results did not meet the requirements of the clinical trial protocol.
-
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.
-
Other situations judged by the investigator to be unsuitable to join this trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of medical Sciences, Peking Union Medical College | Nanjing | Jiangsu | China | 210000 |
Sponsors and Collaborators
- Beijing InnoCare Pharma Tech Co., Ltd.
Investigators
- Principal Investigator: Qianjin Lu, Hospital for Skin Diseases, Chinese Academy of medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ICP-CL-01001