Overview
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.
Eligibility
Inclusion Criteria:
Participants are eligible to be included in the study only if ALL of the following criteria
apply:
1. 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.
2. Participants assigned male at birth who are ≥18 years and ≤45 years old at the time of
signing the ICF.
3. 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.
4. 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:
1. Hematology and coagulation results within reference ranges.
2. 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.
3. 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.
5. 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.
6. 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.
7. 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.
8. 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.
Exclusion Criteria:
Participants are excluded from the study if ANY of the following criteria apply:
1. Known or suspected hereditary or acquired complement deficiency.
2. History of meningococcal infection.
3. History or evidence of a clinically significant disorder (including psychiatric
disorders), condition, or disease that, in the opinion of the Investigator and Medical
Monitor or designee, would pose a risk to participant safety or interfere with the
study evaluation, procedures, or completion. EXCEPTION: Fully resolved childhood
asthma is not exclusionary.
4. History of splenectomy.
5. History of surgery or major trauma within 12 weeks of Screening, or surgery planned
during the study.
6. 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.
7. 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).
8. History of ongoing seborrheic dermatitis or eczema.
9. 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.
10. History of recurrent/chronic hemorrhages or any hemorrhage within 30 days prior to IP
administration.
11. History of a drug- or food-induced severe hypersensitivity reaction (eg, immunologic
or nonimmunologic anaphylaxis).
12. Known hypersensitivity reaction to penicillin and/or cephalosporin that, in the
opinion of the Investigator, would pose a risk to participant safety.
13. Known hypersensitivity to any component of TUR03 or Soliris, murine proteins, or other
monoclonal antibodies.
14. 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.
15. 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.
16. Proteinuria at Screening or Day -1 (with a urine dipstick value of 1+ or above)..
17. Tests positive for human immunodeficiency virus (HIV 1 and 2), hepatitis B virus
surface antigen, hepatitis B core antibody, or hepatitis C virus.
18. Tests positive for tuberculosis (TB) using the QuantiFERON®-TB Gold test at Screening
or, if indeterminant result on the first test, tests positive or indeterminant on
repeat QuantiFERON-TB Gold test.
19. Positive screen for alcohol by breath test and/or potential drugs of abuse by urine
drug screen at Screening or Day -1. NOTE: One repeat screen is allowed at the
discretion of the Investigator.
20. History of alcohol or drug abuse or drug addiction (including cannabis products)
within the last 12 months prior to Screening.
21. Prior exposure to eculizumab or similar compounds (ie, a monoclonal antibody that
specifically binds to the complement protein C5).
22. Use of immunoglobulins or iron supplementation within 3 months prior to Screening.
23. Use of any over-the-counter (OTC) medications, herbal remedies such as St. John's Wort
extract, or prescription medications within 7 days or 5 half lives (whichever is
longer) prior to IP administration. EXCEPTIONS: Vitamins, dietary supplements, and
paracetamol (up to 4 g per day, but <1 g in 4 hours) for analgesia are not
exclusionary.
24. Use of other investigational drugs (or is currently using an investigational device)
within 60 days or 5 half-lives (whichever is longer) prior to IP administration.
25. Vaccination with a live vaccine within 30 days prior to IP administration, or
vaccination with an inactivated vaccine or approved COVID-19 vaccine within 14 days
prior to IP administration, or planning to get vaccinated during the study period.
EXCEPTIONS: Receipt of required meningococcal vaccinations per protocol is not
exclusionary.
26. Veins unsuitable for venous blood collection.
27. Donated blood (including blood products) or experienced loss of blood ≥500 mL within
30 days of Screening, or donated plasma within 7 days of Screening.
28. Participant is a family member or employee of the Investigator or Sponsor.