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Tests treatment safety and results for Psoriasis
Official title Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118
ClinicalTrials.gov ID: NCT06846710
What this study is testing
What is HS-20118?
HS-20118 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for psoriasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- For the SAD study:
- Healthy adults aged 18-45 years (inclusive) at the time of signing the informed consent form;
- Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg; body mass index (weight/square of height (kg/m2)) within...
- Normal results or abnormal results but without clinical significance in comprehensive examinations, including general physical examination, vital...
- Male or female participants aged 18-65 years (inclusive) at the time of signing the informed consent form;
You likely can't join if
- For the SAD study:
- Participants with immune-related diseases and medical history at screening;
- Participants with a history of drug or other allergies who are considered by the investigator to be at high risk for participating in this study, or...
- History of drug abuse within the past 5 years or use of illicit drugs within 3 months before the study; or positive for urine drug screening; For the...
- Guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced psoriasis, or other diseases that affect the treatment results;
- Current use of illicit drugs or prior use of illicit drugs within the specific time periods;
See the full eligibility criteria
- For the SAD study:
- Healthy adults aged 18-45 years (inclusive) at the time of signing the informed consent form;
- Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg; body mass index (weight/square of height (kg/m2)) within the range of 18-28 kg/m2 (inclusive);
- Normal results or abnormal results but without clinical significance in comprehensive examinations, including general physical examination, vital signs, laboratory tests, 12-lead ECG, abdominal color Doppler ultrasound...
- Male or female participants aged 18-65 years (inclusive) at the time of signing the informed consent form;
- Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg;
- Chronic plaque psoriasis for at least 6 months with or without psoriatic arthritis;
- For the SAD study:
- Participants with immune-related diseases and medical history at screening;
- Participants with a history of drug or other allergies who are considered by the investigator to be at high risk for participating in this study, or who may be allergic to the investigational medicinal product or any...
- History of drug abuse within the past 5 years or use of illicit drugs within 3 months before the study; or positive for urine drug screening; For the MAD study:
- Guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced psoriasis, or other diseases that affect the treatment results;
- Current use of illicit drugs or prior use of illicit drugs within the specific time periods;
- Known history of recurrent or chronic infections, or prior history of chronic or recurrent infections, including but not limited to: chronic renal infection, chronic chest infection (e.g., bronchiectasis), symptomatic...
The study team makes the final eligibility decision.
Where it's taking place
- Anaheim, California, United States
- Miami Lakes, Florida, United States
- Pompano Beach, Florida, United States
- Takapuna, Auckland, New Zealand
- Christchurch, Christchurch, New Zealand
- Dunedin, Dunedin, New Zealand
- Pukekohe, Pukekohe, New Zealand
- Upper Hutt, Upper Hutt, New Zealand
- Mount Cook, Wellington Region, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anaheim, California, United States; Miami Lakes, Florida, United States; Pompano Beach, Florida, United States; Takapuna, Auckland, New Zealand; Christchurch, Christchurch, New Zealand; Dunedin, Dunedin, New Zealand and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.