Actively Recruiting
Evaluation of the Safety, Tolerability and Pharmacokinetics of HY6725 in Healthy Adult Participants
Led by Newsoara Biopharma Co., Ltd. · Updated on 2026-03-11
74
Participants Needed
1
Research Sites
59 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 HY6725 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 HY6725 in healthy adult participants? * What is the PK character of HY6725 following administration of single and multiple doses of HY6725 in healthy adult participants? Researchers will compare HY6725 to a placebo (a look-alike substance that contains no drug) to see if HY6725 is safe and well tolerated. Participants will take HY6725 or a placebo once or twice in single dose group or multiple dose group. And will be follow-up until Day 150.
CONDITIONS
Official Title
Evaluation of the Safety, Tolerability and Pharmacokinetics of HY6725 in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 55 years at consent
- Clinically healthy based on medical history, physical exam, vital signs, lab tests, and ECG
- Willing and able to follow all study visits, treatments, tests, and procedures
- Body mass index between 18 and 32 kg/m2 and body weight over 50 kg
- Able to provide signed informed consent and comply with study requirements
You will not qualify if you...
- History or evidence of significant blood, kidney, hormone, lung (except resolved childhood asthma), digestive (except resolved gall bladder or appendix removal), heart, liver, mental health, neurological, or allergic diseases (except untreated seasonal allergies)
- History or positive tests for HIV, hepatitis B or C, or syphilis
- History of severe allergic or anaphylactic reactions to drugs
- Recent active infections within 28 days before screening
- Recent iron deficiency treatment within 3 months before first dose
- Fever within 48 hours before dosing
- Positive QuantiFERON-TB test
- Medical or psychiatric conditions that increase risk or make participation unsuitable
- Use of prescription medications within 14 days or over-the-counter medications within 7 days before study drug (with some exceptions)
- Recent exposure to live vaccines within 28 days before screening
- Prior exposure to anti-TSLP or anti-IL-33 therapies
- Use of investigational drugs within 30 days or 5 half-lives before first dose
- Positive urine drug test
- Positive pregnancy test
- High blood pressure above specified thresholds despite repeated measurements
- Abnormal baseline ECGs affecting safety or study interpretation
- Significant abnormal lab test results including liver enzymes and bilirubin
- History of drug or alcohol abuse or binge drinking within 6 months
- Blood donation of about 500 mL within 30 days before dosing
- History of heparin sensitivity or induced low platelet count
- Unwillingness or inability to follow lifestyle requirements
- Investigator site staff, sponsor employees involved in the study, or their family members
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nucleus Network Pty Ltd.
Melbourne, 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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