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This study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RLYB116 (with an improved impurity profile) following repeated administration of RLYB116 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RLYB116 Dose 1 | Experimental | RLYB116 for Injection Dose 1, weekly for 5 weeks |
|
| RLYB116 Dose 2 | Experimental | RLYB116 for Injection Dose 2, weekly for 5 weeks |
|
| Placebo for Injection | Placebo Comparator | Sodium chloride injection, 0.9% saline (for both RLYB116 doses), weekly for 5 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RLYB116 for Injection | Drug | RLYB116 is a small protein composed of an Affibody® Z-domain that binds with high affinity to C5, inhibiting terminal complement activation, and an albumin binding domain (ABD) that extends the effective plasma half-life of the protein by targeting serum albumin. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment related adverse events as defined by CTCAE 5.0. | From baseline to Day 1, 2, 3, 4, 5, 8, 9, 15, 16, 22, 23, 29, 30, 32, 33, 36, 43, 57, 71, 99 |
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of complement activation measured by free/total C5 concentrations and hemolytic activity | Day 1, 2, 8, 15, 29, 20, 32, 33, 43, 57, 71, 99 | |
| Anti-RLYB116 antibodies measured in serum | Day 1, 29, 99 |
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Inclusion Criteria:
Male and female participants, 18 to 55 years of age.
Able to provide written informed consent.
Body mass index (BMI) of 18.0 to 32.0 kg/m2.
Must have been vaccinated against N. meningitidis and S. pneumoniae with approved vaccine according to product label. All participants considered eligible for enrollment will be vaccinated or willing to receive vaccination according to the following:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Brisbane | Brisbane | Queensland | 4006 | Australia |
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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Exposure to RLYB116 as measured in serum | Day 1, 2, 3, 4, 5, 8, 15, 29, 53, 57, 71, 99 |