Phase I Study of HXN6005 in Adult Healthy Participants

NCT07449741 | Recruiting Phase 1

• 1 other identifier: HXN6005-A1-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Healthy Volunteers (HV)

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Adverse Events

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to Day 141

Secondary Outcomes (5)

• Cmax

  Up to Day 141

• Tmax

  Up to Day 141

• t1/2

  Up to Day 141

• AUC

  Up to Day 141

• ADA

  Up to Day 141

Other Outcomes (1)

• Exploratory PD biomarker

  Up to Day 141

Study Arms (2)

Single-Ascending Dose (SAD) of HXN6005

EXPERIMENTAL

Participants will receive a single dose of HXN6005 (Cohort 1-4)

Drug: HXN6005

Single-Ascending Dose (SAD) of placebo

PLACEBO COMPARATOR

Participants will receive single dose of Placebo

Drug: Placebo

Interventions

HXN6005 DRUG

participants will receive a single subcutaneous dose of HXN6005 at escalating dose levels in Cohort 1-4,

Single-Ascending Dose (SAD) of HXN6005

Placebo DRUG

Participants will receive matching placebo across cohorts 1-4 of the study.

Single-Ascending Dose (SAD) of placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• 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 (e.g., basal cell carcinoma, squamous cell carcinoma) that have been successfully treated/excised for more than 12 months;
• Have known type I/II diabetes;
• Positive for human immunodeficiency virus antibodies, syphilis antibodies, hepatitis B surface antigen, or hepatitis C antibodies;
• Positive for drugs use before randomization;
• 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;
• 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;
• 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;
• Known exposure to any type of antibody or anti-TSLP therapy within 5 half-lives before randomization;
• 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;
• 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;
• 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;
• Participants with herpes zoster reactivation or cytomegalovirus that resolved within 60 days before randomization;

Sponsors & Collaborators

• Helixon Biotechnology (Suzhou) Co., Ltd: lead

Study Sites (1)

Veritus Research

Bayswater, Victoria, 3153, Australia

RECRUITING

Central Study Contacts

Gang Tong

CONTACT

(86)13918569690; tonggang@helixon.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): March 13, 2027
• Study Completion (Estimated): March 13, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)