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

Phase 1

Not yet recruiting

• Conditions: Hematologic Diseases; Autoimmune Diseases
• Interventions: Drug: RLYB116 for Injection

• Registration Number: NCT06797375
• Lead Sponsor: Rallybio

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28
• Study Start: 2025-03
• Primary Completion: 2026-04
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RLYB116 Dose 1	RLYB116 for Injection	RLYB116 for Injection Dose 1, weekly for 5 weeks
RLYB116 Dose 2	RLYB116 for Injection	RLYB116 for Injection Dose 2, weekly for 5 weeks
Placebo for Injection	RLYB116 for Injection	Sodium chloride injection, 0.9% saline (for both RLYB116 doses), weekly for 5 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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