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A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response

RecruitingPhase 1Ages 18 Years - 55 YearsAllAdaxion Therapeutics
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In plain words

What the trial is, and whether it could suit you

This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of subcutaneous and intravenous ADX-001 in healthy adult participants

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Provide informed consent - Be willing and able to sign a consent form after understanding the study and before any study-related procedures are performed. * Age - Be a healthy adult male or female aged 18 to 55 years. * Body weight and BMI - Have a Body Mass Index (BMI) between 18.0 and 32.0 kg/mยฒ. Weigh more than 50 kg and less than 120 kg. * For women who can become pregnant - Have a negative pregnancy test before participating. * Use highly effective birth control during the study and for 15 months after the last study dose. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: 1. Medical Conditions * You have a serious or ongoing health condition affecting the heart, lungs, liver, kidneys, digestive system, hormones, nervous system, immune system, or mental health. * You have a history of severe allergic reactions, anaphylaxis, or are allergic to the study drug or its ingredients. 2. Infections * You test positive for HIV, hepatitis B, or hepatitis C. * You have tuberculosis (TB), a history of TB, recent close contact with someone who has active TB, or a positive TB screening test. * You test positive for COVID-19 before receiving the study drug. * You have an active or long-term infection requiring treatment. * You have needed antibiotics or other anti-infective treatment within the last month. * You were hospitalized or required intravenous (IV) treatment for an infection within the last 3 months. * You have a history of certain recurring infections, such as shingles (herpes zoster). * You have a fever higher than 37.7ยฐC during screening or within 7 days before dosing. * In some cases, minor abnormalities may be accepted if the study doctor considers them not clinically important. 4\. Heart and Blood Pressure Problems 5. Previous Medications or Treatments * You have previously received medicines that target TNFฮฑ or IL-23. * You have received other biologic medicines within the last 6 months. * You have used medicines that significantly suppress the immune system within the required washout period. * You have recently used prescription or over-the-counter medications that could affect study results. * You received a live vaccine within the last 12 weeks or any other vaccine within the last 4 weeks. * You donated blood, plasma, or platelets too recently before joining the study. 6\. Alcohol or Drug Use. 7. Pregnancy and Reproductive Considerations * You are pregnant, breastfeeding, or planning to become pregnant during the study period. * You are unwilling to use the required birth control methods. 8\. Participation in Other Research Studies * You have recently participated in another clinical trial involving an investigational drug or device. * You have previously participated in this study. 9\. Ability to Participate * You are unable to understand the study requirements or provide informed consent. * You are unable or unwilling to follow study procedures and visit schedules. 10\. Conflict of Interest * You are an employee of the study sponsor or investigator, or an immediate family member of one. 11\. Other Safety Concerns * The study doctor believes that participating could put your health at risk, prevent you from completing the study, or affect the reliability of the study results.
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What it tests

  • ADX-001
  • ADX-001
  • Placebo
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Where

1 site
CMAX Clinical Research
Adelaide, Australia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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