A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of SNP318 in Healthy Adult Participants

SciNeuro1 site in 1 country76 target enrollmentMarch 20, 2023

ConditionsNeurodegenerative Diseases Alzheimer's Disease

InterventionsPlacebo (B)SNP318 (A)

Overview

Phase: Phase 1
Intervention: Placebo (B)
Conditions: Neurodegenerative Diseases
Sponsor: SciNeuro
Enrollment: 76
Locations: 1
Primary Endpoint: Safety and tolerability of SNP318 in healthy adult participants. Assessed by adverse events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

SNP318 is developed to treat neurodegenerative diseases including Alzheimer's disease. In the current phase 1 study, the IP is tested in healthy volunteers, and the purpose is to investigate the safety, tolerability, and PK of single and multiple ascending oral doses of SNP318.

Detailed Description

A total of approximately 86 healthy male and female adult participants aged 18 years and older will be enrolled in this study, that will be conducted in 2 parts: Part 1-Single Ascending Dose (SAD) and Part 2 -Multiple Ascending Dose (MAD). Part 1 is subdivided into Part 1a and Part 1b. Part 1b is a cohort for cerebrospinal fluid sampling. There are 6 cohorts planned for Part 1a SAD, 1 cohort for Part 1b SAD and 3 cohorts for Part 2 MAD.

Registry

clinicaltrials.gov

Start Date

March 20, 2023

End Date

November 29, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

SciNeuro

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant must be ≥18 years of age, at the time of signing the informed consent.
•Participants who are overtly healthy, in the opinion of the Investigator, as determined by medical evaluation including medical history, physical examination, vital signs, ECGs and laboratory tests. Participants who do not qualify based on a reversible condition or mild intercurrent illness may be re-screened after the underlying condition is resolved.
•Body weight between 50.0 and 120.0 kg, inclusive, if male; and between 40.0 and 120.0 kg, inclusive, if female. Body Mass Index within the range ≥19 and ≤30 kg/m2 (inclusive), at screening.
•Female participants who engage in heterosexual intercourse must be of non-childbearing potential, defined as either surgically sterile (ie, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), OR be postmenopausal with at least 1 year of amenorrhea, OR must be using an established form of highly effective method of contraception from the time of screening until at least 90 days after the last dose of study intervention. Female participants must not be lactating and must agree to have no egg donation plan during the study and for 90 days after the last dose of study intervention.
•Male participants must agree to use a condom when sexually active with a female partner of childbearing potential from screening until at least 90 days after the last dose of study intervention (or be surgically sterile \[ie, vasectomy with documentation\]; or remain abstinent, when this is in line with the preferred and usual lifestyle). Male participants should also agree not to donate sperm for the duration of the study and until at least 90 days after the last dose of study intervention.
•Must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria

•Known hypersensitivity, allergy, intolerance, or idiosyncratic reaction to the study intervention, or any of the excipients contained in the intervention formulation. If any history of anaphylaxis or reaction to other agents, discussion with (and approval by) the Investigator and Sponsor is required.
•Any concomitant disease, condition, or treatment that could interfere with the conduct of the study or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the study or interfere with the interpretation of study data.
•History of dysphagia or any gastrointestinal disease (including Gilbert's syndrome) that affects the participants ability to swallow and/or affects drug absorption.
•Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test at any time prior to administration of the study intervention if SARS-CoV-2 test is performed.
•Any clinically significant (at the discretion of the Investigator) abnormalities in laboratory test results. Total bilirubin value up to 1.5 times the upper normal limit of normal can be acceptable if associated with normal conjugated bilirubin value (unless the participant has documented Gilbert's Syndrome).
•History of immunological disorders, auto-immune disorders, acquired or congenital immune deficiency, including autoimmune rheumatic disease.
•Note: participants with mild asthma controlled with occasional rescue inhaler only (no chronic therapy; no inhaled corticosteroids), and mild atopic dermatitis controlled with topic emollients only (no topical corticosteroids) are not excluded.
•Immunization with any live vaccine within 28 days prior to administration of study intervention; or expected to require any live vaccines during study period.
•Evidence at the initial screening visit of active or prior hepatitis B infection based on serological tests for hepatitis B surface antigen (HbsAg).
•Positive serological tests for human immunodeficiency virus (HIV) antibody and/or hepatitis C virus (HCV) antibody at the initial screening visit.

Arms & Interventions

B (Placebo)

Placebo comparator taken by participants randomized to the placebo arm in each cohort in Part 1 and Part 2.

Intervention: Placebo (B)

A (SNP318)

Drug: SNP318, Dose level: Start from 1mg for single ascending dose and from 30mg for multiple ascending dose. Dose levels can be adjusted based on emerging safety, tolerability, pharmacokinetics data of previous cohorts. Dosage form: Capsule Route of administration: Oral

Intervention: SNP318 (A)

Outcomes

Primary Outcomes

Safety and tolerability of SNP318 in healthy adult participants. Assessed by adverse events

Time Frame: Up to 20 days

Secondary Outcomes

Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC)(Up to 20 days)
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Apparent oral clearance (CL/F)(Up to 20 days)
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Apparent volume of distribution at steady state (Vss/F)(Up to 20 days)
The concentration of SNP318 in CSF samples in healthy adult participants(Up to 7 days)
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Maximum concentration (Cmax)(Up to 20 days)
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Time of maximum concentration observed (Tmax)(Up to 20 days)
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Apparent terminal phase half-life (T1/2z)(Up to 20 days)