This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
This is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of 3 different dose regiments of KYN-5356 and placebo for 28 days. Participants will be randomized to one of 4 treatment groups: placebo, KYN-5356 low dose, KYN-5356 medium dose, KYN-5356 high dose. Participants will be admitted to the clinic on Day -3 and will remain in residence at the clinic for 32 days, from baseline through the treatment period. Participants will be administered investigational medicinal product on Days 1 through 28. Efficacy, safety, PK and exploratory PD assessments will be performed throughout the dosing period. Participants will be discharged on Day 29 after safety assessments are completed and return for a follow-up visit on Day 42. A subset of participants from selected sites will undergo electrophysiological assessments to evaluate the effect of KYN-5356 on neurophysiological measures of brain function.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of KYN-5356 as Adjunctive Treatment in Adults With Cognitive Impairment Associated With Schizophrenia
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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Sponsor: Kynexis B.V.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.