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MAD Cohort 3 for Cognitive Impairment

Phase 1
Recruiting
Led By Hakop Gevorkyan, MD, MBA
Research Sponsored by Kynexis B.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (predose) through 72 hours post dosing on day 7.
Awards & highlights

Study Summary

This trial is testing a new drug called KYN-5356. The trial is divided into three parts. In the first two parts, they will test the safety and tolerability of the drug by

Who is the study for?
This trial is for healthy individuals aged 18 to 55 who may be interested in contributing to research on schizophrenia and cognitive impairment. Participants should not have any health conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing KYN-5356, a new potential treatment. It's a three-part study: first, they'll see how people handle different doses; second, they'll check safety with repeated doses; third, they'll look at how food affects the drug's absorption.See study design
What are the potential side effects?
Since this is an early-stage trial for KYN-5356, specific side effects are being investigated. Common side effects in such trials can include nausea, headache, dizziness or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (predose) through 72 hours post dosing on day 7.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (predose) through 72 hours post dosing on day 7. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment-Emergent Adverse Events
Secondary outcome measures
PK parameters: AUCinf [MAD]
PK parameters: AUCinf [SAD]
PK parameters: AUCtau on Days 1 and 7 [MAD]
+6 more

Trial Design

10Treatment groups
Experimental Treatment
Group I: SAD Cohort 6Experimental Treatment2 Interventions
Single-Ascending Dose Cohort 6. Intervention: KYN-5356 F mg or placebo, single dose, oral tablet
Group II: SAD Cohort 5Experimental Treatment2 Interventions
Single-Ascending Dose Cohort 5. Intervention: KYN-5356 E mg or placebo, single dose, oral tablet
Group III: SAD Cohort 4Experimental Treatment2 Interventions
Single-Ascending Dose Cohort 4. Intervention: KYN-5356 D mg or placebo, single dose, oral tablet
Group IV: SAD Cohort 3Experimental Treatment2 Interventions
Single-Ascending Dose Cohort 3. Intervention: KYN-5356 C mg or placebo, single dose, oral tablet
Group V: SAD Cohort 2Experimental Treatment2 Interventions
Single-Ascending Dose Cohort 2. Intervention: KYN-5356 B mg or placebo, single dose, oral tablet
Group VI: SAD Cohort 1Experimental Treatment2 Interventions
Single-Ascending Dose Cohort 1. Intervention: KYN-5356 A mg or placebo, single dose, oral tablet
Group VII: MAD Cohort 3Experimental Treatment2 Interventions
Multiple-Ascending Dose Cohort 3. Intervention: KYN-5356 I mg or placebo, oral tablets for 7 days
Group VIII: MAD Cohort 2Experimental Treatment2 Interventions
Multiple-Ascending Dose Cohort 2. Intervention: KYN-5356 H mg or placebo, oral tablets for 7 days
Group IX: MAD Cohort 1Experimental Treatment2 Interventions
Multiple-Ascending Dose Cohort 1. Intervention: KYN-5356 G mg or placebo, oral tablets for 7 days
Group X: Food Effect CohortExperimental Treatment1 Intervention
Intervention: KYN-5356 J mg, single dose, oral tablets in fasted or fed state.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
placebo
2010
Completed Phase 4
~6580

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Kynexis B.V.Lead Sponsor
ParexelIndustry Sponsor
305 Previous Clinical Trials
101,017 Total Patients Enrolled
Hakop Gevorkyan, MD, MBAPrincipal InvestigatorParexel
1 Previous Clinical Trials
9 Total Patients Enrolled
~0 spots leftby Jul 2024
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