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

NCT06797375 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IPC2401
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

complement-mediated diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

RLYB116 Dose 1

EXPERIMENTAL

RLYB116 for Injection Dose 1, weekly for 5 weeks

Drug: RLYB116 for Injection

RLYB116 Dose 2

EXPERIMENTAL

RLYB116 for Injection Dose 2, weekly for 5 weeks

Drug: RLYB116 for Injection

Placebo for Injection

PLACEBO COMPARATOR

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

Drug: RLYB116 for Injection

Interventions

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.

Placebo for Injection; RLYB116 Dose 1; RLYB116 Dose 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.
• Vaccination with Meningococcal Group B (Bexsero®) at least 14 days prior to receiving the first dose of RLYB116.

You may not qualify if:

• Participants that smoke more than 10 cigarettes per week
• Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus.
• Pregnant or nursing
• Donation or loss of greater than 400 mL of blood within 56 days of study enrollment
• History of severe hypersensitivity to any drug, including penicillin or ciprofloxacin, or to N. meningitidis or S. pneumoniae vaccines.

Sponsors & Collaborators

• Rallybio: lead

Study Sites (1)

Nucleus Network Brisbane

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Hematologic Diseases; Autoimmune Diseases

Interventions

Injections

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: April 14, 2025
• Primary Completion: February 9, 2026
• Study Completion: February 23, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)