A First Time in Human Study of SNP318 as a Treatment for Neurodegenerative Diseases Including Alzheimer's Disease

NCT05792163 | Completed Phase 1 DMC

• 1 other identifier: SNP318-101
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodegenerative Diseases; Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

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

  Up to 20 days

Secondary Outcomes (7)

• 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 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

Study Arms (2)

A (SNP318)

EXPERIMENTAL

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

Drug: SNP318 (A)

B (Placebo)

PLACEBO COMPARATOR

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

Drug: Placebo (B)

Interventions

SNP318 (A) DRUG

Capsule for oral administration

A (SNP318)

Placebo (B) DRUG

Placebo capsules matching the SNP318 capsules

B (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Blood donation of \>400 mL within 3 months before screening or \>200 mL within 4 weeks before screening or plan to donate blood during study period.
• Acute or febrile illness within 7 days prior to the first dose of study intervention or participants with evidence of active infection.
• Evidence of an active or suspected cancer or a history of malignancy within the previous 3 years, except for the following, which did not require systemic therapy and are considered cured: nonmelanoma skin cancer, curatively treated localized prostate cancer, or other in situ cancer.
• History of drug abuse or a positive drug abuse test result at screening or D-1.
• History of alcohol abuse or a positive alcohol test result at screening or D-1.

Sponsors & Collaborators

• SciNeuro: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Neurodegenerative Diseases; Alzheimer Disease

Condition Hierarchy (Ancestors)

Nervous System Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 31, 2023
• Study Start: March 20, 2023
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)