Actively Recruiting
Evaluation of the Safety, Tolerability and Pharmacokinetics of HY8931 in Healthy Adult Participants
Led by Newsoara Biopharma Co., Ltd. · Updated on 2026-03-11
60
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn the safety, tolerability and pharmacokinetics of single and multiple doses of HY8931 in healthy adult participants. The main questions it aims to answer are: * How is the safety and tolerability following administration of single and multiple doses of HY8931 in healthy adult participants? * What is the PK character of HY8931 following administration of single and multiple doses of HY8931 in healthy adult participants? Researchers will compare HY8931 to a placebo (a look-alike substance that contains no drug) to see if HY8931 is safe and well tolerated. Participants will take HY8931 or a placebo once or twice in single dose group or multiple dose group. And will be follow-up until Day 90.
CONDITIONS
Official Title
Evaluation of the Safety, Tolerability and Pharmacokinetics of HY8931 in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 to 45 years at the time of consent
- Participants must be overtly healthy based on medical history, physical exam, lab tests, vital signs, and ECG
- Willing and able to follow all study visits, treatment plans, lab tests, lifestyle rules, and procedures
- Body mass index (BMI) between 18 and 32 kg/m2 and weight over 50 kg
- Capable of giving informed consent and following study requirements and restrictions
You will not qualify if you...
- History or evidence of significant blood, kidney, endocrine, lung, digestive, heart, liver, psychiatric, neurological, or allergic diseases (except untreated seasonal allergies)
- Positive tests for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, HIV, or syphilis at screening
- History of allergic or anaphylactic reaction to any therapeutic drug
- Recent active infections within 28 days before screening
- Fever within 48 hours before dosing
- Positive QFT-G test
- History of more than 3 bacterial infections per year or recurrent herpes simplex virus infections
- Use of certain medications as specified in study protocol
- Recent live vaccine exposure within 28 days before screening or planned during trial
- Known exposure to anti-TL1A or anti-IL23 therapies
- Use of investigational drugs within 90 days or 5 half-lives before first study dose
- Positive urine drug test
- Positive pregnancy test
- Blood pressure readings at screening above specified limits after rest
- ECG abnormalities that may affect safety or study results
- Elevated liver enzymes or bilirubin above specified levels
- History of alcohol abuse, binge drinking, illicit drug use, or smoking more than 5 cigarettes per week within 6 months
- Blood donation of 500 mL or more within 30 days before dosing
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- Unable or unwilling to follow lifestyle considerations in the protocol
- Investigator or sponsor employees involved in the study and their family members
AI-Screening
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Trial Site Locations
Total: 1 location
1
Q-Pharm Pty Ltd.
Brisbane, Australia
Actively Recruiting
Research Team
V
Vandy Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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