A Dose Escalation Phase 1 Study of HXN5003 in Healthy Participants (NCT07549750) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Dose Escalation Phase 1 Study of HXN5003 in Healthy Participants
Australia28 participantsStarted 2026-05-27
Plain-language summary
The goal of this intervention study is to evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HXN5003 in Healthy Participants.The main parameters it aims to answer are:
1. Does a single dose of HXN5003 in healthy participants impact the safety, tolerability and pharmacokinetic profiles?
2. Will immunogenicity of HXN5003 in healthy participants be altered? This study will be compared against a Placebo which contains the same inactive ingredients as those of HXN5003, but without the active ingredient.
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 32 kg/m2, inclusive.
✓. Able to participate and comply with all study procedures and restrictions
✓. 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.
✕. Participant who has history or evidence of any active or suspected infection within the past 14 days prior to randomization;
✕. Participant who has known positive tuberculin skin test or recent exposure to an individual with active tuberculosis (TB), or current clinical or laboratory evidence of active TB.
✕. Participant who has history of malignancy within 5 years before randomization, excluding localized basal cell carcinoma or cutaneous squamous cell carcinoma of the skin that have been resected or cured..
✕. Participant who has known type I/II diabetes.
✕. Positive for human immunodeficiency virus (HIV) antibodies, syphilis test, hepatitis B surface antigen, or hepatitis C antibodies.
What they're measuring
1
Safety and tolerability of HXN5003 in healthy participants following single dose