In relation to the Melbourne trial .Safety, Tolerability,...

In relation to the Melbourne trial .


Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPG302 in Healthy Volunteers and ALS ParticipantsJuly 6, 2023

updated: SpinogenixA phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study in healthy volunteers and an expanded cohort of adult participants with amyotrophic lateral sclerosis (ALS) to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SPG302.

The first phase 1 human study described here will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPG302 in healthy ALS volunteers and participants.

Study OverviewSTATUSrecruitingCONDITIONSamyotrophic lateral sclerosisINTERVENTION/TREATMENTMedicine: placeboMedicine: SPG302DETAILED DESCRIPTIONThis study is a phase 1, randomized, double-blind, placebo-controlled, single-dose and multiple-dose escalation study in HV with a food effect cohort and a dose escalation cohort(s) in participants with ALS.

The study consists of 3 parts, namelyart 1: SAD in HV with up to 6 cohorts including a nutritional effects cohort.Part 2: MAD for 5 days in HV with up to 5 cohortsPart 3: Once-daily (QD) dosing cohorts of ALS patients for 28 days.

STUDY TYPEInterventionalREGISTRATION (RATED)112PHASEPhase 1Contacts and locationThis section provides contact information for individuals conducting the study and information about where the study is conducted.

RESEARCH CONTACTSName : Public queriesPhone number : +61 1800 243 733Email : [email protected] CONTACTS BACKUPName : Ofer M Gonen, MDPhone number : +61 3 8593 9800Email : [email protected] of studyAustraliaVictoriaMelbourne, Victoria, Australia, 3004recruitingNucleus MelbourneContact:Cameron JohnsonPhone number : +61 3 8593 9800Email :[email protected] criteriaResearchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health or prior medical treatment.Acceptance CriteriaAGE SUITABLE FOR LEARNINGAdultACCEPTS HEALTHY VOLUNTEERSYesDESCRIPTIONInclusion Criteria:Age 18-55