Actively Recruiting
Phase I Study of HXN6005 in Adult Healthy Participants
Led by Helixon Biotechnology (Suzhou) Co., Ltd · Updated on 2026-04-24
32
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HXN6005 in Healthy Participants. Researchers will compare HXN6005 to a placebo (a look-alike substance that contains no drug). Participants will take a single dose of HXN6005 or placebo on Day 1, and visit the clinic for followup and tests per the protocol scheme.
CONDITIONS
Official Title
Phase I Study of HXN6005 in Adult Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedure.
- Male and female participants aged between 18 to 55 years, inclusive.
- Participants must have a body mass index between 18 to 35 kg/m2, inclusive.
- Healthy participants, in the opinion of the Investigator and as determined by medical history, with normal or clinically acceptable physical examination, clinical laboratory tests and ECG results at Screening and before randomization.
- Female participants must be postmenopausal, surgically sterile, or, if of childbearing potential, agree to use highly effective contraception combined with a condom from screening until 180 days post-dose, and refrain from egg donation or in vitro fertilization during this period.
- Male participants, with their female partner of childbearing potential, agree to use a condom as well as highly effective contraception, and refrain from sperm donation and in vitro fertilization until 180 days after the dosing of the study drug.
- Participants must be willing to understand and comply with all research procedures and restrictions, and able to communicate effectively with researchers.
You will not qualify if you...
- Females who are pregnant, planning to become pregnant, or lactating during the trial.
- History of febrile illness or evidence of any active or suspected infection within 30 days before randomization.
- Participant at risk for tuberculosis.
- History of malignancy within 5 years before randomization, except for non-melanoma skin cancers that have been successfully treated/excised for more than 12 months.
- Known type I or type II diabetes.
- Positive for human immunodeficiency virus antibodies, syphilis antibodies, hepatitis B surface antigen, or hepatitis C antibodies.
- Positive for drug use before randomization.
- Use of nicotine or tobacco products within 3 months prior to dosing, or unwilling to abstain during confinement.
- History of alcohol abuse or unwillingness to abstain from alcohol for 48 hours prior to admission.
- Recent use of experimental agents within 30 days or 5 half-lives before randomization.
- Known exposure to antibody or anti-TSLP therapy within 5 half-lives before randomization.
- Donated blood (about 500 mL or more) within 30 days before randomization or planning to donate during the trial or within 30 days after.
- Use of prescription or over-the-counter drugs or supplements within 7 days or 5 half-lives before randomization.
- Recent vaccination with live vaccines within 30 days or non-live vaccines within 2 weeks before randomization, or planning to receive vaccines during the trial.
- Herpes zoster reactivation or cytomegalovirus resolved within 60 days before randomization.
- Clinically significant interventional therapies within 6 months before randomization or planned surgeries during the trial.
- History of significant hypersensitivity reactions to biologic agents, therapeutic proteins, or relevant excipients.
- Any other condition that increases risk for participation, as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Veritus Research
Bayswater, Victoria, Australia, 3153
Actively Recruiting
Research Team
G
Gang Tong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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