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

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/m². 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 37.7°C 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 TNFα 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.