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MAD Cohort 1 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (predose) through 72 hours post dosing on day 7.

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

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ParexelIndustry Sponsor

304 Previous Clinical Trials

101,072 Total Patients Enrolled

Kynexis B.V.Lead Sponsor

Hakop Gevorkyan, MD, MBAPrincipal InvestigatorParexel

1 Previous Clinical Trials

9 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still eligible to participate in this ongoing research?

"Indeed, the details on clinicaltrials.gov indicate that this ongoing clinical trial is actively seeking participants. The trial was initially posted on December 21st, 2023 and was most recently updated on January 16th, 2024. They aim to recruit a total of 80 patients from a single designated site."

Answered by AI

What is the collective count of participants who are joining this medical research study?

"Indeed, the information provided on clinicaltrials.gov confirms that this trial is currently seeking eligible patients. The trial was initially posted on December 21, 2023 and most recently updated on January 16, 2024. The study aims to enroll a total of 80 participants from a single location."

Answered by AI

Which criteria must individuals meet in order to be eligible for enrollment in this clinical trial?

"Individuals diagnosed with schizophrenia and aged between 18 and 55 years old are eligible for this clinical trial. The study aims to recruit approximately 80 participants who meet these criteria."

Answered by AI

Are individuals aged 65 and above eligible to participate in this clinical trial?

"As per the eligibility requirements outlined in this trial, individuals aged 18 to 55 are eligible for participation."

Answered by AI

What is the level of safety observed in patients participating in SAD Cohort 1?

"Given that this trial is in Phase 1, indicating limited available safety and efficacy data, our team at Power rates the safety of SAD Cohort 1 as a score of 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of KYN-5356 in Healthy Subjects Aged 18 to 55 Years

2023. "A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of KYN-5356 in Healthy Subjects Aged 18 to 55 Years". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06225115.

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