New drug HXN6005 tested in healthy volunteers for first time
NCT ID NCT07449741
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 1 trial tests the safety and tolerability of a single dose of HXN6005 in 32 healthy adults aged 18 to 55. Participants receive either the drug or a placebo and are monitored for side effects and how the drug moves through the body. The study is still recruiting and does not aim to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HXN6005
- What could go wrong
- This is an early Phase 1 study in healthy volunteers, so it cannot show any treatment benefit. The drug may prove unsafe or ineffective in later trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Veritus Research
RECRUITINGBayswater, Victoria, 3153, Australia
Contact Email: •••••@•••••
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