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Clinical Trial NCT07449741 for Healthy Volunteers (HV) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Phase I Study of HXN6005 in Adult Healthy Participants Phase 1 40 Single Dose

Not yet recruiting
Clinical Trial NCT07449741 is designed to study Treatment for Healthy Volunteers (HV). This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on 27 April 2026 until the study accrues 40 participants. Led by Helixon Biotechnology (Suzhou) Co., Ltd, this study is expected to complete by 13 March 2027. The latest data from ClinicalTrials.gov was last updated on 6 March 2026.
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.

Detailed Description
This study consists of 5 Cohorts, including three sequential ascending-dose cohorts (Cohort 1,2 and 4), and two paralleled cohorts (Cohort 3 and 5).

The investigator and participants will be blinded to treatment assignment. Participants in different dose groups will be enrolled from the low-dose group to the high-dose group.

Eight healthy participants will be randomly enrolled per cohort. In cohort 1,2,4 and 5, the...

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Official Title

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

Conditions
Healthy Volunteers (HV)
Other Study IDs
  • HXN6005-A1-101
NCT ID Number
NCT07449741
Start Date (Actual)
2026-04-27
Last Update Posted
2026-03-06
Completion Date (Estimated)
2027-03-13
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Sequential
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSingle-Ascending Dose (SAD) of HXN6005
Participants will receive a single dose of HXN6005 (Cohort 1-5)
HXN6005
participants will receive a single subcutaneous dose of HXN6005 at escalating dose levels in Cohort 1-4, and a single intravenous dose of HXN6005 in Cohort 5.
Placebo ComparatorSingle-Ascending Dose (SAD) of placebo
Participants will receive single dose of Placebo
Placebo
Participants will receive matching placebo across cohorts 1-5 of the study.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Cmax
Maximum concentration after single ascending dose
Up to Day 141
Tmax
Time to reach maximum concentration after single ascending dose
Up to Day 141
t1/2
Half life after single ascending dose
Up to Day 141
AUC
Area under the concentration-time curve after single ascending dose
Up to Day 141
ADA
Incidence of anti-drug antibody after single ascending dose
Up to Day 141
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  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.

  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;
  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 any hypersensitivity or allergic reaction to any drug;
  18. Have any other conditions that would, in the opinion of the investigator, put the participants at increased risk for participation in this trial.
Helixon Biotechnology (Suzhou) Co., Ltd logoHelixon Biotechnology (Suzhou) Co., Ltd
Study Central Contact
Contact: Gang Tong, (86)13918569690, [email protected]
1 Study Locations in 1 Countries

Victoria

Veritus Research, Bayswater, Victoria, 3153, Australia
Veritus Research, Contact, 03 8736 1758, [email protected]
Emir Redzepagic, Dr., Principal Investigator