Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RLYB116 in Healthy Participants

Rallybio

Status and phase: Active, not recruiting; Phase 1

Conditions: Autoimmune Diseases; Hematologic Diseases

Treatments: Drug: RLYB116 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06797375

IPC2401

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

16 participants in 3 patient groups, including a placebo group

RLYB116 Dose 1

Experimental group

Description:

RLYB116 for Injection Dose 1, weekly for 5 weeks

Treatment:

Drug: RLYB116 for Injection

RLYB116 Dose 2

Experimental group

Description:

RLYB116 for Injection Dose 2, weekly for 5 weeks

Treatment:

Drug: RLYB116 for Injection

Placebo for Injection

Placebo Comparator group

Description:

Sodium chloride injection, 0.9% saline (for both RLYB116 doses), weekly for 5 weeks

Treatment:

Drug: RLYB116 for Injection