First-in-Human Study of RLYB116 in Healthy Participants

Phase 1

Completed

• Conditions: complement mediated diseases; Blood - Haematological diseases; Inflammatory and Immune System - Autoimmune diseases

• Registration Number: ACTRN12621001571864
• Lead Sponsor: IPC Research, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-18
• Study Completion: 2024-01-25
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

1. Males and females age 18 to 55 years.
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 according to the following:
a. Vaccination with Meningococcal Group A, C, W135, and Y conjugate vaccine (Menveo®) + Pneumococcal Polysaccharide Vaccine (Pneumovax® 23) at least 28 days prior to receiving the first dose of RLYB116.
b. 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: Not specified

Primary Outcome Measures

Name	Time	Method
Part A/Part B: To assess the safety and tolerability of RLYB116 in healthy participants following single and repeated administration adverse events<br>• Incidence and severity of adverse events (AE) (Adverse events will be coded using the Medical Dictionary for Regulatory Activities) <br>• vital signs (Tympanic temperature, pulse rate, respiratory rate via pulse oximeter and blood pressure by sphygmomanometer)<br>• clinical laboratory values (Hematology, clinical chemistry and Coagulation) measured using blood samples<br>• electrocardiogram (ECG)<br>[ Part A: From baseline to Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 15, Day 29, Day 43, Day 57, and Day 71 post-intervention administration. <br><br>Part B: From baseline to Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 9, Day 11 (B7 only), Day 15, Day 16, Day 18 (B7 only), Day 22, Day 23, Day 25 (B7 only), Day 29, Day 30, Day 32, Day 33, Day 36, Day 43, Day 57, Day 71 and Day 99 post-intervention administration.<br>]