Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants

NCT05863442 | Unknown Phase 1

• 1 other identifier: TUR03-22-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a randomized, double-blind, parallel-group study to evaluate the PK, safety, tolerability, immunogenicity, and PD of TUR03 compared to Soliris, when administered as a single IV infusion in healthy adult male participants.

Conditions

Healthy

Keywords

eculizumab; phase I; biosimilar

Outcome Measures

Primary Outcomes (1)

• PK similarity of TUR03 and Soliris following a single IV infusion in healthy participants

  The primary endpoint for PK similarity is AUC(0-inf).

  Day 1 - Day 57

Secondary Outcomes (60)

• Eculizumab serum concentration-time profile

  Day 1 - Day 57

• Maximum serum concentration (Cmax)

  Day 1- Day 57

• Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)

  Day 1- Day 57

• Time to Cmax

  Day 1 - Day 57

• Terminal half-life

  Day 1 - Day 57

Study Arms (2)

Soliris

ACTIVE COMPARATOR

Drug: Soliris 300 MG in 30 ML Injection

TUR03

EXPERIMENTAL

Drug: TUR03 300 MG in 30 ML Injection

Interventions

Soliris 300 MG in 30 ML Injection DRUG

Active Comparator

Soliris

TUR03 300 MG in 30 ML Injection DRUG

Investigational medicinal Product, eculizumab - Turgut

TUR03

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are eligible to be included in the study only if ALL of the following criteria apply:
• Capable of giving signed informed consent as described in Section 10.1, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
• Participants assigned male at birth who are ≥18 years and ≤45 years old at the time of signing the ICF.
• Body weight ≥50 kg and ≤90 kg and body mass index (BMI) ≥18.00 kg/m2 and ≤30.00 kg/m2 at Screening and Day -1.
• Participants must be healthy as determined by the Investigator, based on medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations at Screening and Day -1, as follows:
• Hematology and coagulation results within reference ranges.
• Liver function panel analyte values ≤1.5 × upper limits of normal (ULN), which include aspartate transaminase, alanine transaminase, and total bilirubin (for participants with Gilbert's Syndrome, total bilirubin ≤3.0 × ULN is allowed if direct bilirubin is ≤50%), alkaline phosphatase, and gamma glutamyl transferase at Screening.
• Urinalysis within reference ranges or showing no clinically significant findings.
• NOTE: One repeat of clinical laboratory tests is allowed at the discretion of the Investigator.
• Participants must have documented evidence of prior complete vaccination with meningococcal vaccines against N. meningitidis serogroup B at any time and against serogroups A, C, W, and Y within 5 years prior to Screening in line with local immunization requirements or must agree to be vaccinated against N. meningitidis during the study.
• Nonsterilized participants with partners of childbearing potential must agree to take appropriate contraceptive measures (as described in Section 10.4) from Day 1 until 5 months after IP administration and refrain from donating sperm during this period. NOTE: Participants with pregnant partners are excluded.
• Nonsmoker or occasional smoker, ie, smokes ≤10 cigarettes (or equivalent of tobacco- or nicotine-containing products) per week within 30 days prior to Screening and is able to abide by the smoking policy of the study site.
• Ability and willingness to abstain from alcohol from 48 hours before admission to the study site on Day -1, during in-house observation at the study site until discharge, and for 24 hours prior to ambulatory visits.

You may not qualify if:

• Participants are excluded from the study if ANY of the following criteria apply:
• Known or suspected hereditary or acquired complement deficiency.
• History of meningococcal infection.
• History of splenectomy.
• History of surgery or major trauma within 12 weeks of Screening, or surgery planned during the study.
• A recent history (within 1 week prior to IP administration) or presence or suspicion of current active systemic or local infection, a known risk for developing sepsis, and/or known active inflammatory condition, in the opinion of the Investigator.
• History of or current invasive malignancy (excluding basal or squamous cell carcinoma that has been fully resected with no evidence of metastatic disease for 1 year).
• History of ongoing seborrheic dermatitis or eczema.
• History of clinically significant headaches that, in the opinion of the Investigator, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
• History of recurrent/chronic hemorrhages or any hemorrhage within 30 days prior to IP administration.
• History of a drug- or food-induced severe hypersensitivity reaction (eg, immunologic or nonimmunologic anaphylaxis).
• Known hypersensitivity reaction to penicillin and/or cephalosporin that, in the opinion of the Investigator, would pose a risk to participant safety.
• Known hypersensitivity to any component of TUR03 or Soliris, murine proteins, or other monoclonal antibodies.
• Known hypersensitivity to any component of meningococcal vaccines, including those containing diphtheria toxoid, or a life-threatening reaction after previous administration of a vaccine containing similar components.
• Hypertension at Screening or Day -1 (defined as a systolic blood pressure \[BP\] \>140 mm Hg and/or a diastolic BP \>90 mm Hg, confirmed by a single repeat measurement that same day) or a history of hypertension requiring pharmacological intervention.

Sponsors & Collaborators

• Turgut Ardika PTY LTD: lead

Study Sites (1)

Q-Pharm Pty Limited

Herston, Queensland, Australia

RECRUITING

MeSH Terms

Interventions

eculizumab; Injections

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: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: May 18, 2023
• Study Start: April 10, 2023
• Primary Completion: July 23, 2024
• Study Completion: October 5, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

AU (1)