Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005510-33 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ANX105 administered intravenously (IV) to healthy participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANX105 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANX105 | Biological | Participants will receive single-ascending doses of ANX105 administered by IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Treatment-Emergent Adverse Events | Up to Week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Serum Total Hemolytic Complement (CH50) | Blood samples will be obtained to determine the amount of CH50. | Up to Week 7 |
| Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Olga Bandman, MD | Annexon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Annexon Investigational Site 02 | Groningen | Netherlands | ||||
| Annexon Investigational Site 01 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Placebo-controlled single ascending dose study.
Not provided
Not provided
Not provided
| Placebo | Drug | Participants will receive matching placebo administered by IV infusion. |
|
Blood samples will be obtained to determine the amount of C1q.
| Baseline, Week 7 |
| Amount of C1q in Cerebrospinal fluid (CSF) | CSF samples will be obtained to determine the amount of C1q. | Up to Week 7 |
| Serum Concentrations of ANX105 | Blood samples will be obtained to determine serum concentrations of ANX105. | Up to Week 7 |
| Maximum Observed Serum Concentration (Cmax) of ANX105 | Blood samples will be obtained to determine the Cmax of ANX105. | Up to Week 7 |
| Area Under the ANX105 Serum Concentration-Time Curve (AUC) | Blood samples will be obtained to determine the AUC of ANX105. | Up to Week 7 |
| CSF Concentrations of ANX105 | CSF samples will be obtained to determine CSF concentrations of ANX105. | Up to Week 7 |
| Leiden |
| Netherlands |