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NCT05633745
A Study to Assess NEU-723 in Healthy Participants
Conditions: Healthy
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 64
Sponsor: Neuron23 Inc.
Location: New Zealand
Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), multiple ascending dose (MAD), of orally administered NEU-723 in healthy subjects.
Eligibility Criteria
Inclusion Criteria:Subjects for standard cohorts must be 18-80 years, inclusive, at the time of signing the informed consent;Subjects who are in good general health with no clinically relevant abnormalities based on the medical history, physical examinations, neurological examinations, clinical laboratory evaluations (hematology and clinical chemistry)Subjects who have a body mass index (BMI) of 18-32 kg/m2(inclusive);Male subjects are eligible to participate if they are rendered surgically sterile (at least 6 months), or agree to the following during the study and for at least 30 days after the last dose of study drug:• Refrain from donating sperm;AND, either:Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; ORAgree to use a male condom (contraception/barrier) and should also be advised of the benefit for a female partner to use an acceptable, highly effective method of contraception as a condom may break or leak when having sexual intercourse;Female subjects are eligible to participate if they are not pregnant or breastfeeding, subject to one of the following:Women of childbearing potential (WOCBP), defined as women physiologically capable of becoming pregnant, must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test on Day -1; WOCBP must agree to use an acceptable, highly effective contraceptive method from Screening until 30 days after the last dose of study treatment (see Section 11.3); ORMenopausal women must have an elevated serum follicle-stimulating hormone level (FSH) level at Screening; if the FSH is not elevated, they are considered to be of childbearing potential (unless permanently sterile) and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1;Exclusion Criteria:History of clinically significant hematological, renal, pancreatic, gastrointestinal, hepatic, cardiovascular, metabolic, endocrine, immunological, allergic disease, or other major disordersHistory of clinically significant abnormal chest x-rayClinically significant neurologic disorderContraindications to undergo a lumbar puncture (only for subjects participating in the MAD)
Source: ClinicalTrials.gov (NCT05633745). StuddyBuddy aggregates publicly available trial information.