Autoimmune Diseases, Hematologic Diseases
Conditions
Keywords
complement-mediated diseases
Brief summary
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.
Interventions
DRUGRLYB116 for Injection
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.
Sponsors
Rallybio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female participants, 18 to 55 years of age. 2. Able to provide written informed consent. 3. Body mass index (BMI) of 18.0 to 32.0 kg/m2. 4. 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: 1. Vaccination with Meningococcal Group A, C, W135, and Y conjugate vaccine (Menveo® or an acceptable alternative) + Pneumococcal Polysaccharide Vaccine (Pneumovax® 23 or an acceptable alternative) at least 28 days prior to receiving the first dose of RLYB116. 2. Vaccination with Meningococcal Group B (Bexsero®) at least 14 days prior to receiving the first dose of RLYB116.
Exclusion criteria
1. Participants that smoke more than 10 cigarettes per week 2. Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus. 3. Pregnant or nursing 4. Donation or loss of greater than 400 mL of blood within 56 days of study enrollment 5. History of severe hypersensitivity to any drug, including penicillin or ciprofloxacin, or to N. meningitidis or S. pneumoniae vaccines.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| Exposure to RLYB116 as measured in serum | Day 1, 2, 3, 4, 5, 8, 15, 29, 53, 57, 71, 99 |
Countries
Australia
Outcome results
None listed