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Single Dose Study of ANX005 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03010046
Recruitment Status : Terminated (ANX005 well tolerated at doses studied; study discontinued and initiated in patient population)
First Posted : January 4, 2017
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Annexon, Inc.

Brief Summary:
This is a single-center, randomized, double-blind, placebo-controlled, ascending, single-infusion, sequential group study. Single, ascending doses will be administered to approximately 64 subjects, with an option for 1 additional multi-dose cohort in approximately 8 subjects. The primary objective is to evaluate the safety of ANX005 administered as an intravenous infusion as a single agent and in combination with intravenous immunoglobulin (IVIg). The optional multi-dose cohort will evaluate either additional subjects at the maximum tolerated dose or ANX005 administered as 2 infusions.

Condition or disease Intervention/treatment Phase
Safety and Tolerability in Healthy Volunteers Drug: ANX005 Drug: IVIg Drug: Placebos Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Placebo-controlled, Double Blind, Single, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ANX005 Monotherapy and ANX005 in Combination With IVIg in Healthy Volunteers
Study Start Date : December 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: ANX005 Monotherapy
ANX005 intravenous infusion
Drug: ANX005
Single ascending dose intravenous infusion

Experimental: ANX005 and IVIg Combination Therapy
ANX005 intravenous infusion in combination with intravenous immunoglobulin (IVIg)
Drug: ANX005
Single ascending dose intravenous infusion

Drug: IVIg
IVIg infusion in Cohorts 4b and 5b only. Randomized to ANX005 followed by IVIg or placebo followed by IVIg.

Placebo Comparator: Placebo
Placebo intravenous infusion
Drug: Placebos
0.9% saline intravenous infusion




Primary Outcome Measures :
  1. Number of subjects with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: Day 43 ]
    Safety is assessed throughout the study. Day 43 is the last visit.


Secondary Outcome Measures :
  1. Peak plasma concentration [ Time Frame: Day 43 ]
  2. Determine effective dose of ANX005 [ Time Frame: Day 43 ]
    Percent of subjects with a biologic response, defined as a reduction of serum CH50 percent change from baseline at 21 and 28 days after the first ANX005 infusion

  3. Area under the plasma concentration versus time curve (AUC) [ Time Frame: Day 43 ]
  4. Terminal half-life [ Time Frame: Day 43 ]

Other Outcome Measures:
  1. Explore relationship of AUC with PD responses in serum [ Time Frame: Day 43 ]
  2. Explore relationship of AUC with PD responses in CSF [ Time Frame: Day 43 ]
  3. Explore relationship of half-life with PD responses in serum [ Time Frame: Day 43 ]
  4. Explore relationship of half-life with PD responses in CSF [ Time Frame: Day 43 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and females 18 years and older
  • Females must be postmenopausal, surgically sterilized, or willing and able to use 2 methods of contraception throughout the study and for 1 month after the final study visit
  • Willing and able to undergo vaccination if not vaccinated recently

Exclusion Criteria:

  • History of any autoimmune disease, meningitis, septicemia or pneumonia
  • History of hypercoagulable diseases, hyperviscosity, thrombosis, renal dysfunction or acute renal failure
  • Known genetic deficiencies of the complement cascade system
  • History of conditions whose symptoms and effects could alter protein catabolism or IgG utilization, e.g. protein-losing enteropathies or nephrotic syndrome
  • Body weight less than 50 kg or greater than 100 kg
  • Hypersensitivity or allergic reactions to any excipients in the ANX005 drug product
  • (Cohorts 4b and 5b) Known selective IgA deficiency or presence of antibodies to IgA at screening
  • (Cohorts 4b and 5b) Prior reaction or hypersensitivity to blood products, including IVIg or any of the excipients in IVIg.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010046


Locations
Australia, Victoria
Nucleus Network
Melbourne, Victoria, Australia
Sponsors and Collaborators
Annexon, Inc.
Investigators
Study Director: Sandy Calman, MD Annexon Medical Monitor
Principal Investigator: Jason Lickliter, MBBS PhD Nucleus Network Ltd

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Annexon, Inc.
ClinicalTrials.gov Identifier: NCT03010046     History of Changes
Other Study ID Numbers: ANX005-CP01
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No