A Single and Multiple Ascending Dose Study of ANX009 in Normal Healthy Volunteers (NHV)

Launched by ANNEXON, INC. · Aug 27, 2020

Keywords

ClinConnect Summary

In this first in human, phase 1, randomized, double-blind, placebo-controlled study, single and multiple ascending doses of ANX009 or placebo will be administered to 48 healthy subjects.

Single Ascending Dose (SAD): Each SAD subject will participate for approximately 4 weeks (3 nights in-clinic confinement).

Multiple Ascending Dose: Each MAD subject will participate for approximately 6 weeks (17 nights in-clinic confinement).

All subjects will be contacted (in clinic visit or phone call) 6 months after study completion.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy male and non-pregnant, non-lactating female volunteers ≥18 to 59 years of age.
• • 2. Females must be postmenopausal, surgically sterilized or willing and able to use highly effective methods of contraception from screening through the final study visit.
• • 3. Males with a partner of childbearing potential must agree to use contraception from Screening through the final study visit.
• • 4. Documented history within 5 years of screening of previous vaccination against encapsulated bacterial pathogens (MAD cohorts only).
• • 5. Complete the full sequence of protocol-related doses, procedures and evaluations.
• • 6. No alcohol and drugs of abuse at screening and baseline or through study completion.
• • 7. Discontinue use of nutritional supplements and prescription and over-the-counter medications (vitamins are allowed).
• • 8. No new tattoos/piercings or elective surgery from screening through the End of Study visit
• • 9. Ability to understand and provide written informed consent.
• Exclusion Criteria:
• Subjects must not meet any of the following criteria:
• • 1. Clinically significant, ongoing illness or medical condition that would jeopardize the safety of the subject, limit participation, or compromise the interpretation of the safety data derived from the subject.
• • 2. Clinically significant findings on the screening or Baseline ECG or physical examination.
• • 3. Clinically significant abnormalities on screening or Baseline laboratory assessments.
• • 4. An ANA titer ≥ 1:160.
• • 5. History of any autoimmune disease.
• • 6. History of meningitis or septicemia.
• • 7. Clinically significant infection that required medical intervention (not including antibiotic prophylaxis) within 1 month prior to study drug dosing.
• • 8. Known genetic deficiencies of the complement cascade system or immunodeficiency.
• • 9. Treatment with an investigational therapeutic agent within 30 days prior to study drug dosing.
• • 10. Use of immunosuppressants or corticosteroids within 30 days prior to study drug dosing.
• • 11. Active alcohol abuse, drug abuse or substance abuse.
• • 12. Hypersensitivity to any of the excipients in the ANX009 drug product or active substance.
• • 13. History of previous sensitivities or allergic or anaphylactic reactions to previous medication injections.
• • 14. Positive for HIV Ab, Hepatitis C Ab or Hepatitis B surface antigen (HBsAg) at screening.
• • 15. Body weight less than 50 kg or greater than 125 kg.
• • 16. BMI less than 18 or greater than 30 (Asians greater than 27).
• • 17. Current smoker defined as any occasional or daily smoking of tobacco products