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

NCT ID: NCT06797375

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-14
• Study Completion Date: 2026-06-30

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.

Conditions

Hematologic Diseases; Autoimmune Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RLYB116 Dose 1

RLYB116 for Injection Dose 1, weekly for 5 weeks

Group Type: EXPERIMENTAL

RLYB116 for Injection

Intervention Type: 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.

RLYB116 Dose 2

RLYB116 for Injection Dose 2, weekly for 5 weeks

Group Type: EXPERIMENTAL

RLYB116 for Injection

Intervention Type: 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.

Placebo for Injection

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

Group Type: PLACEBO_COMPARATOR

RLYB116 for Injection

Intervention Type: 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.

Interventions

RLYB116 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rallybio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nucleus Network Brisbane

Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

IPC2401

Identifier Type: -

Identifier Source: org_study_id