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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.
Full description
Up to five (5) single-ascending oral doses will be administered to 40 healthy adult male or female subjects (aged 18-80 years, inclusive). Escalation to the next higher dose level may occur only after evaluation of the safety and PK results of the previous dose level (at least 6 evaluable subjects). Within each cohort, 6 subjects will receive one dose of NEU-723, and 2 subjects will receive one dose of matching placebo. Dose levels may be revised based on available safety and PK data.
Multiple ascending oral doses will be administered up to 24 healthy subjects (aged 18 - 80 years, inclusive) in 3 sequential dosing groups (8 subjects in each dosing group). Six (6) subjects will receive NEU-723 and two (2) subjects will receive matching placebo in each dosing group (cohort) for 7 days. Escalation to the next higher dose level may occur only after evaluation of the safety and PK results of the previous dose level (at least 6 evaluable subjects). Dose levels may be revised based on available safety and PD data.
Enrollment
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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:
Female subjects are eligible to participate if they are not pregnant or breastfeeding, subject to one of the following:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups, including a placebo group
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Central trial contact
Sam Jackson, MD
Data sourced from clinicaltrials.gov
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