Safety and Tolerability in Healthy Volunteers Clinical Trial
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
Verified date | August 2020 |
Source | Annexon, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 27 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Australia | Nucleus Network | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Annexon, Inc. |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Explore relationship of AUC with PD responses in serum | Day 43 | ||
Other | Explore relationship of AUC with PD responses in CSF | Day 43 | ||
Other | Explore relationship of half-life with PD responses in serum | Day 43 | ||
Other | Explore relationship of half-life with PD responses in CSF | Day 43 | ||
Primary | Number of subjects with treatment-related adverse events as assessed by CTCAE v4.03 | Safety is assessed throughout the study. Day 43 is the last visit. | Day 43 | |
Secondary | Peak plasma concentration | Day 43 | ||
Secondary | Determine effective dose of ANX005 | 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 | Day 43 | |
Secondary | Area under the plasma concentration versus time curve (AUC) | Day 43 | ||
Secondary | Terminal half-life | Day 43 |
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