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New treatment option for Healthy Volunteers (HV)
Official title Phase I Study of HXN6005 in Adult Healthy Participants
ClinicalTrials.gov ID: NCT07449741
What this study is testing
What is HXN6005?
HXN6005 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy volunteers (hv).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join 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...
- Female participants must be postmenopausal, surgically sterile, or, if of childbearing potential, agree to use highly effective contraception...
You likely can't join 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)...
- Have known type I/II diabetes;
- Positive for human immunodeficiency virus antibodies, syphilis antibodies, hepatitis B surface antigen, or hepatitis C antibodies;
See the full eligibility criteria
- 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...
- 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...
- 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...
- Participants must be willing to understand and comply with all research procedures and restrictions, and able to communicate effectively with researchers.
- 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...
- 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...
- 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;
- Have clinically significant treatment therapies (surgery, paracentesis, etc.) within 6 months before randomization, or plan to have any surgeries during the trial;
- History of clinically significant hypersensitivity reactions to biologic agents, therapeutic proteins, or to specific excipients relevant to the study drug formulation.
- Have any other conditions that would, in the opinion of the investigator, put the participants at increased risk for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Bayswater, Victoria, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bayswater, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.