Phase I Study of HXN6005 in Adult Healthy Participants (NCT07449741) | Clinical Trial Compass
RecruitingPhase 1
Phase I Study of HXN6005 in Adult Healthy Participants
Australia32 participantsStarted 2026-04-27
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion 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 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.
Exclusion criteria
✕. 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;
What they're measuring
1
Number of Participants Experiencing Adverse Events
✕. 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;