Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
NCT Number: NCT04920903
The study is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety and tolerability of COR588 HCl in healthy male and female subjects.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Melbourne, Victoria, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Increasing doses of COR588 will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase.
Placebo will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase.
Time frame: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Assessment of the incidence and severity of treatment-emergent adverse events.
Time frame: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Assessment of changes in serum chemistry measures.
Time frame: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Assessment of changes in hematology measures.
Time frame: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Assessment of changes in urinalysis parameters.
Time frame: To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase.
Area under the concentration-time curve
Time frame: To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase.
Maximum observed drug concentration during a dosing interval
Time frame: To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase.
Time to Cmax
Cortexyme Inc.
Industry
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-in-Human, Single- and Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Oral COR588 in Healthy Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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