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PsoriasisPhase 1NCT05451199

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

A Phase 1 study testing ICP-488 in people with Psoriasis, run by Beijing InnoCare Pharma Tech Co., Ltd. at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Psoriasis
What is being tested?
ICP-488
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
154 participants
Where
7 sitesChina
Study dates
29 Jul 2022to 31 Dec 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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；
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  • All of the following 3 criteria are met at screening and randomization:
  • 1）Psoriasis Area and Severity Index (PASI) ≥ 12; 2）Physician Global Assessment (PGA) ≥ 3; 3）Body surface area (BSA) affected by psoriasis ≥ 10%.
  • 8. The subject is a candidate to receive systemic therapy and/or phototherapy.

Who cannot join

  • 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.
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  • 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.
  • Last use of stron , moderate and weak CYP1A2/CYP3A4 inhibitors or inducers less than 5 half-lives before the first dose of study drug, or planning to take medications, dietary supplements, or foods
  • 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.
  • Any positive showed in the lab result of syphilis specific antibody, hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or human immunodeficiency virus serological antibody (HIV-Ab) during screening.
  • 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.
  • Non-plaque forms of psoriasis.
  • Drug-induced psoriasis.
  • Are taking or require oral or injectable corticosteroids for any medical condition.
  • Clinically significant test results at the time of screening that, in the investigator's judgment, may cause unacceptable risk to the participant.
  • History of active tuberculosis，active hepatitis B virus、active hepatitis C virus or Syphilis infection.
  • Clinically severe, progressive, or uncontrolled disease at screening； Pregnant female subjects.
  • breastfeeding female subjects.
  • Other situations judged by the investigator to be unsuitable to join this trial.

Trial locations and contacts

7 sites in 1 country.

Lisa Zhao contact

+86 18233150939

Lisa.zhao@innocarepharma.com

7 sites in 1 country

China7 sites, 7 recruiting

  • Hangzhou First People's Hospital

    Hangzhou, Zheajing, 310006

    Liming Wu

    Not yet recruiting

  • The Second Hospital of Anhui Meidcal University

    Hefei, Anhui, 230601

    Chunjun Yang

    Not yet recruiting

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

    Nanjing, Jiangsu, 210000

    Qianjin Lu

    Recruiting

  • Nanyang First People's Hospital

    Nanyang, Henan, 473004

    Rixin Chen

    Not yet recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Guoqiang Zhang

    Not yet recruiting

  • Shiyan Renmin Hospital

    Shiyan, Hubei, 442000

    Zudong Meng

    Recruiting

  • Yanbian University Hospital

    Yanji, Jilin, 133000

    Zhehu Jin

    Not yet recruiting

Other trials in China

About this study

Official title: 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

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
Being tested
ICP-488, Placebo
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICP-488Drug

    ICP-488 will be administered as tablet

  • PlaceboDrug

    Matching placebo will be administered as tablet

Study groups in NCT05451199
Study groupRoleWhat they receive
ICP-488ExperimentalSingle ascending doses of ICP-488 tablet; Multiple ascending doses of ICP-488 tablet; Part3 Patients with Psoriasis:ICP-488 tablet.
Receives: Drug: ICP-488
PlaceboPlacebo comparatorSingle ascending doses of placebo; Multiple ascending doses of placebo; Part3 Patients with Psoriasis of placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (6)

  1. Cmax

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

  2. Psoriasis Area and Severity Index （PASI）

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

  3. Body Surface Area （BSA）

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

  4. Static Physician's Global Assessment （sPGA）

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

  5. Peak Pruritus Numerical Rating Scale （PP-NRS）

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

  6. Dermatology quality of life index （DLQI）

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start29 Jul 2022
  3. Primary completion30 Oct 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05451199
Sponsor's protocol ID
ICP-CL-01001
Status last verified
Apr 2023
First submitted
24 Jun 2022
Last updated
18 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ICP-488 in people with Psoriasis, run by Beijing InnoCare Pharma Tech Co., Ltd. at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lisa Zhao (+86 18233150939, Lisa.zhao@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events during treatment, and withdrawal from treatment due to adverse events (time frame: Single ascending dose: 1day；Multiple ascending dose: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05451199.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.

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