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

NCT ID: NCT04535752

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2021-06-26

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmakokinetics and pharmacodynamics of single and repeated doses of ANX009

Detailed Description

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.

Conditions

Safety and Tolerability in Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

ANX009, Single Ascending Doses

Single dose of ANX009 with a 7-day follow-up before escalation to the next dose level.

Group Type: EXPERIMENTAL

ANX009

Intervention Type: DRUG

Single or multiple ascending dose

Placebo, Single Ascending Doses

Single doses of matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single or multiple ascending dose

ANX009, Multiple Ascending Doses

ANX009 once daily on Days 1-14

Group Type: EXPERIMENTAL

ANX009

Intervention Type: DRUG

Single or multiple ascending dose

Placebo, Multiple doses

Matching placebo once daily on Days 1-14

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single or multiple ascending dose

Interventions

ANX009

Single or multiple ascending dose

Intervention Type: DRUG

Placebo

Single or multiple ascending dose

Intervention Type: DRUG

Other Intervention Names

009; matching placebo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nucleus Network Ltd

OTHER

Sponsor Role: collaborator

Annexon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Humphriss, MBA

Role: STUDY_DIRECTOR

Annexon Director, Global Clinical Operations

Locations

Site 1

Melbourne, , Australia

Countries

Australia

Other Identifiers

ANX009-NHV-01

Identifier Type: -

Identifier Source: org_study_id