A phase 1/2, prospective, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of single and multiple ascending doses of intravenously administered ZRC-NB-3224 in healthy adult participants and in patients with paroxysmal nocturnal hemoglobinuria - NI

Zydus Lifesciences Ltd0 sites0 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

•Single ascending dose study:
•1\.Male and non\-pregnant, non\-lactating, female participants aged 18 to 50 years at screening (both inclusive).
•2\.Body mass index between 18\.5 to 29\.9 kg/m2 (both inclusive) and body weight \=50 kg at screening.
•3\.Ability to communicate effectively with study personnel.
•4\.Be able to give consent for participation in the trial.
•5\.Healthy as determined based on personal medical/surgical history, physical examination, ECG, and laboratory assessment data during screening (within the clinically acceptable range).
•6\.Vaccinated against Neisseria meningitides with meningococcal group ACWY conjugate vaccine and meningococcal group B vaccine, Streptococcus pneumoniae, Haemophilus influenzae
•7\.Female participants with a history of sterility or at least 1 year menopause or use of long\-acting non\-hormonal contraceptive measures (e.g., intrauterine device). Those who are willing and able to continue contraception till study completion after administration of study treatment.
•8\.Men who agree to use adequate contraception methods during the study and are willing and able to continue contraception till study completion after administration of study treatment.
•Multiple ascending dose study:

•Single ascending dose study:
•1\.History of alcohol consumption or tobacco use or drug abuse within past 1 year of enrolment or participant currently consuming alcohol and/or tobacco products.
•2\.Presence or history of any of the disorder/disease within the past 3 months that might have an impact on the clinical trial as per the investigator’s discretion i.e., cardiovascular, nervous system, gastrointestinal, respiratory or any other major disorder.
•3\.Presence or suspicion of active viral, bacterial, fungal, or parasitic infection within 14 days before administration of the first dose of study drug.
•4\.Difficulty in donating blood.
•5\.Systolic blood pressure more than 140 mmHg or lesser than 100 mmHg and diastolic blood pressure more than 90 mmHg or less than 60 mmHg.
•Multiple ascending dose study:
•1\.Known or suspected hereditary or acquired complement deficiency.
•2\.History of clinically significant arterial or venous thrombosis.
•3\.History of hematopoietic stem cell transplantation.

Not specified