Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000594-21 | 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
Not provided
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ANX1502 (prodrug) and ANX1439 (active drug) in healthy participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANX1502 SAD | Experimental | Participants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo. |
|
| ANX1502 MAD | Experimental | Participants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANX1502 | Drug | ANX1502 is a prodrug of ANX1439. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose and Multiple Doses of ANX1502 | Day 1 (after dosing) through Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma ANX1502 and ANX1439 Concentrations After A Single Dose and Multiple Doses of ANX1502 | Predose up Day 29 | |
| Maximum Observed Plasma Concentration (Cmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502 | Predose up Day 29 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Olga Bandman | Annexon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Annexon Investigational Site 01 | Groningen | Netherlands |
Not provided
This study consists of single-ascending dose (SAD), food effect, and multiple-ascending dose (MAD) parts.
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo comparator. |
|
| Observed Time to Cmax (Tmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502 | Predose up to Day 29 |
| Area Under the Concentration-time Curve (AUC) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502 | Predose up Day 29 |
| Terminal Half-life (t1/2) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502 | Predose up to Day 29 |