A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis
NCT ID: NCT07024602
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
94 participants
INTERVENTIONAL
2025-06-30
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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SAD Cohort 1
Participants will receive a single ASC50 (Dose 1) administration or matching placebo
ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
SAD Cohort 2
Participants will receive a single ASC50 (Dose 2) administration or matching placebo
ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
SAD Cohort 3
Participants will receive a single ASC50 (Dose 3) administration or matching placebo
ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
SAD Cohort 4
Participants will receive a single ASC50 (Dose 4) administration or matching placebo
ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
SAD Cohort 5
Participants will receive a single ASC50 (Dose 5) administration or matching placebo
ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
SAD Cohort 6
Participants will receive a single ASC50 (Dose 6) administration or matching placebo
ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
MAD Cohort 1
Participants will receive ASC50 (Dose 1) or matching placebo for 28 days, QD
ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
MAD Cohort 2
Participants will receive ASC50 (Dose 2) or matching placebo for 28 days, QD
ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
MAD Cohort 3
Participants will receive ASC50 (Dose 3) or matching placebo for 28 days, QD
ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
Interventions
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ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
Eligibility Criteria
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Inclusion Criteria
2. Willing and able to give informed consent prior to any study specific procedures being performed.
3. Have venous access sufficient to allow for blood sampling
Exclusion Criteria
2. History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety during the clinical study or expose the subject to undue risk as judged by the Investigator.
3. Have received systemic immunosuppressive therapy (MTX, apremilast, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of first administration of study drug.
4. Have any other conditions, which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.
18 Years
65 Years
ALL
Yes
Sponsors
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Ascletis Pharma (China) Co., Limited
INDUSTRY
Responsible Party
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Locations
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Ascletis Clinical Site
Miami, Florida, United States
Countries
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Central Contacts
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Other Identifiers
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ASC50-101
Identifier Type: -
Identifier Source: org_study_id
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