Single-dose HXN6005 testing in healthy adults

A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamics of HXN6005 in Healthy Participants

This will try a single dose of HXN6005 or a placebo in healthy adults to see if the drug is safe and how it behaves in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Helixon Biotechnology (Suzhou) Co., Ltd (Industry-sponsored)
• Locations: 1 site (Bayswater, Victoria)
• Trial ID: NCT07449741 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled single-ascending-dose study of HXN6005 in healthy adults. Four cohorts are planned, including three sequential ascending-dose cohorts and one parallel cohort, with sentinel dosing in selected cohorts. Eight participants per cohort will be randomized to receive HXN6005 or placebo, blood samples will be taken after Day 1 dosing for pharmacokinetic and pharmacodynamic analyses, and safety will be monitored. Participants will be followed for up to about 141 days with the final follow-up timing possibly adjusted based on emerging safety and PK data.

Who should consider this trial

Good fit: Healthy men and women aged 18–55 with BMI 18–35 who meet screening labs/ECG/physical exam criteria and agree to required contraception (when applicable) are the intended participants.

Not a fit: People with active medical conditions or those seeking direct therapeutic benefit are unlikely to receive clinical benefit from participating in this healthy volunteer study.

Why it matters

Potential benefit: If findings show acceptable safety and predictable drug behavior, the results could enable further clinical testing that may eventually lead to patient treatments.

How similar studies have performed: Single-ascending-dose, placebo-controlled Phase 1 studies in healthy volunteers are a standard and well-established first step that commonly define safe dose ranges and PK profiles, though they do not demonstrate clinical effectiveness.

Eligibility criteria

Inclusion Criteria:

1. Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedure.
2. Male and female participants aged between 18 to 55 years, inclusive.
3. Participants must have a body mass index between 18 to 35 kg/m2, inclusive.
4. 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.
5. 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.
6. 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.
7. Participants must be willing to understand and comply with all research procedures and restrictions, and able to communicate effectively with researchers.

Exclusion Criteria:

1. Females who are pregnant, planning to become pregnant, or lactating during the trial;
2. History of febrile illness or evidence of any active or suspected infection within 30 days before randomization;
3. Participant at risk for tuberculosis;
4. History of malignancy within 5 years before randomization, except for non-melanoma skin cancers (e.g., basal cell carcinoma, squamous cell carcinoma) that have been successfully treated/excised for more than 12 months;
5. Have known type I/II diabetes;
6. Positive for human immunodeficiency virus antibodies, syphilis antibodies, hepatitis B surface antigen, or hepatitis C antibodies;
7. Positive for drugs use before randomization;
8. Have used nicotine or tobacco containing products within 3 months prior to dosing, or unwilling to abstain from the use of tobacco or nicotine containing products during confinement in the CRU;
9. Have a history of alcohol abuse (alcohol consumption in excess of 14 units per week (1 unit contains 14g alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) in the past one year before randomization, or unwilling to abstain from alcohol for 48 hours prior to admission to the CRU;
10. Have received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 30 days or 5 half-lives before randomization, or plan to receive another experimental agent during the trial;
11. Known exposure to any type of antibody or anti-TSLP therapy within 5 half-lives before randomization;
12. Have donated blood (excluding plasma donations) of approximately 1 pint (500 mL) or more within 30 days before randomization, or those who plan to donate blood during the trial or within 30 days after the end of the study;
13. Use of prescription or over-the-counter drugs or dietary or herbal supplements within 7 days or 5 half-lives (whichever is longer) before randomization;
14. Recent exposure to live vaccines within 30 days, or non-live vaccines (including mRNA COVID/flu) within 2 weeks before randomization, or plan to receive vaccines during the trial;
15. Participants with herpes zoster reactivation or cytomegalovirus that resolved within 60 days before randomization;
16. Have clinically significant interventional therapies (surgery, paracentesis, etc.) within 6 months before randomization, or plan to have any surgeries during the trial;
17. History of clinically significant hypersensitivity reactions to biologic agents, therapeutic proteins, or to specific excipients relevant to the study drug formulation.
18. Have any other conditions that would, in the opinion of the investigator, put the participants at increased risk for participation in this trial.

Where this trial is running

Bayswater, Victoria

• Veritus Research — Bayswater, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Gang Tong

Conditions Healthy Volunteers