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OpenTrials
Completed

NCT Number: NCT06797375

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

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.

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Key information

Conditions

Hematologic Diseases Autoimmune Diseases Hemic and Lymphatic Diseases Immune System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Brisbane

Brisbane, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Number of participants with treatment related adverse events as defined by CTCAE 5.0.

    Time frame: 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

  1. Inhibition of complement activation measured by free/total C5 concentrations and hemolytic activity

    Time frame: Day 1, 2, 8, 15, 29, 20, 32, 33, 43, 57, 71, 99

  2. Anti-RLYB116 antibodies measured in serum

    Time frame: Day 1, 29, 99

  3. Exposure to RLYB116 as measured in serum

    Time frame: Day 1, 2, 3, 4, 5, 8, 15, 29, 53, 57, 71, 99

Sponsors and collaborators

Lead sponsor

Rallybio

Industry

Registry information

Official study title

Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RLYB116 in Healthy Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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