Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118

Part of paid clinical trials in Anaheim, California.

Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study ID
NCT06846710
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • HS-20118 — DRUG
    Single and multiple ascending doses of HS-20118 orally
  • HS-20118 placebo — OTHER
    Single and multiple ascending doses of HS-20118-matched placebo orally

Study Details

The study will be conducted in 2 parts (SAD for Part 1 and MAD for Part2). Part 1 is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of HS-20118 after a single oral dose in healthy participants. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability, immunogenicity, PK, and PD of HS-20118 after multiple oral doses in patients with moderate to severe plaque psoriasis .

Key Dates

Start date
May 2, 2025
Status verified
Feb 2025
Primary completion
Oct 30, 2026
Completion
Feb 28, 2027

Study Design

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

Arms

  • Experimental: HS-20118
    Single and multiple ascending doses of HS-20118 orally
  • Placebo Comparator: placebo
    Single and multiple ascending doses of HS-20118-matched placebo orally

Primary Outcome Measure

Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation [ Time Frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Kinetic Clinical ResearchAnaheimCalifornia92806
Marguerite Critelli
[email protected]
(714) 441-9178
Clinitiative - Floridian Clinical Research, LLCMiami LakesFlorida33016
William Eduardo Sanchez
[email protected]
(305) 330-9977
NuLine Clinical Trial Center (Network)Pompano BeachFlorida33060
Steven Glanz
[email protected]
(855)-501-1071

Find similar trials in Anaheim, CA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Kinetic Clinical Research· Anaheim, CAClinitiative - Floridian Clinical Research, LLC· Miami Lakes, FLNuLine Clinical Trial Center (Network)· Pompano Beach, FL

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