A Phase I, Randomized, Double-blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of ASC50 Tablets in Healthy Adult Participants and Adult Participants With Mild to Moderate Plaque Psoriasis
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• Male and female participants between 18 to 65 years of age inclusive, at the time of screening.
• Willing and able to give informed consent prior to any study specific procedures being performed.
• Have venous access sufficient to allow for blood sampling
Locations
United States
Florida
Ascletis Clinical Site
RECRUITING
Miami
Contact Information
Primary
Vanessa Wang, MD
global.clinical@ascletis.com
+86 18986192094
Time Frame
Start Date: 2025-06
Estimated Completion Date: 2026-06
Participants
Target number of participants: 94
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Ascletis Pharma (China) Co., Limited