This is a randomized, triple-blind (subjects, Investigators, and Sponsor blinded), placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study to evaluate the safety and tolerability of NVG-291 administered by subcutaneous injection daily in healthy female participants. The trial is split into three parts, starting with Part 1 (SAD), then Part 2 (MAD - post-menopausal Females), and finally Part 3 (MAD - males and premenopausal females). In Part 1 (SAD), participants receive 1 dose on 1 day only and in Parts 2 and 3, participants receive 1 dose every day for 14 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
74
Nucleus Networks
Melbourne, Victoria, Australia
Adverse Events
number and frequency of adverse events
Time frame: Assessed through 7 days following the last dose of study drug
Pharmacokinetic analysis (plasma)
measure of concentration of drug in blood plasma
Time frame: Assessed on Day 1 (SAD and MAD) and Day 14 (MAD only)
Immunogenicity analysis
number of participants with confirmed and titer results for the presence of anti-drug antibodies
Time frame: Assessed on Day 1 (SAD and MAD), Day 8 (SAD and MAD) and Day 21 (MAD only)
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