Phase I Study of HXN6005 in Adult Healthy Participants

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.