A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis

Part of paid clinical trials in Miami, Florida.

Sponsor
Ascletis Pharma (China) Co., Limited
Study ID
NCT07024602
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • ASC50 tablets or matching placebo — DRUG
    Drug: ASC50 administered orally Drug: Placebo administered orally

Study Details

This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, food effect of ASC50 tablets in healthy adult participants and adult participants with mild to moderate plaque psoriasis.

Key Dates

Start date
Jun 30, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SAD Cohort 1
    Participants will receive a single ASC50 (Dose 1) administration or matching placebo
  • Experimental: SAD Cohort 2
    Participants will receive a single ASC50 (Dose 2) administration or matching placebo
  • Experimental: SAD Cohort 3
    Participants will receive a single ASC50 (Dose 3) administration or matching placebo
  • Experimental: SAD Cohort 4
    Participants will receive a single ASC50 (Dose 4) administration or matching placebo
  • Experimental: SAD Cohort 5
    Participants will receive a single ASC50 (Dose 5) administration or matching placebo
  • Experimental: SAD Cohort 6
    Participants will receive a single ASC50 (Dose 6) administration or matching placebo
  • Experimental: MAD Cohort 1
    Participants will receive ASC50 (Dose 1) or matching placebo for 28 days, QD
  • Experimental: MAD Cohort 2
    Participants will receive ASC50 (Dose 2) or matching placebo for 28 days, QD
  • Experimental: MAD Cohort 3
    Participants will receive ASC50 (Dose 3) or matching placebo for 28 days, QD

Primary Outcome Measure

Adverse Events [ Time Frame: Up to Day 7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ascletis Clinical SiteMiamiFlorida33144-

Find similar trials in Miami, FL

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Ascletis Clinical Site· Miami, FL

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