Neurodegenerative DiseasesPhase 1NCT05792163
A First Time in Human Study of SNP318 as a Treatment for Neurodegenerative Diseases Including Alzheimer's Disease
A Phase 1 study testing SNP318 (A) in people with Neurodegenerative Diseases and Alzheimer's Disease, run by SciNeuro at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases, Alzheimer's Disease
- What is being tested?
- SNP318 (A)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Mar 2023to 29 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Use of prescription medications or herbal remedies within 14 days or 5 elimination half-lives (whichever is longer) of study intervention administration or use of over the counter (OTC) drugs within 7 days of study intervention administration (apart from recommended doses of vitamin/mineral supplements, OTC analgesics, or other agents that have been discussed with and approved by the Investigator and Sponsor). Participants who used recommended doses of paracetamol/ibuprofen for acute conditions (e.g., headache) will not be excluded. Participants who have been on hormone replacement therapy (HRT) or oral contraception for a period of at least 2 months prior to the start of screening will not be excluded from the study, provided the contraceptive or HRT regimen will remain unchanged during the conduct of the study.
- Use of any known liver enzyme inducer or liver enzyme inhibiting food or beverage (such as all citrus fruits including tangerine, grapefruit, sweet orange, lime, kumquat, citron, orange, lemon, etc., and fruit juices) within 7 days prior to administration.
- Any major surgery within 6 months before screening, or plan to have a surgery during the study period.
- Any other conditions that the Investigator considers may affect the participants' informed consent or adherence to the study protocol, completion of the test according to the study procedure, or the participants' participation in the test may affect the test results or their own safety.
- Receipt of another study intervention within 1 month or 5 elimination half-lives (whichever is longer) prior to administration of the study intervention.
- Abnormal cardiac conditions and ECG:
- The Fridericia algorithm corrected QT interval (QTcF) of ECG during screening period is >450 ms for males and >470 ms for females or is considered abnormal with clinical significance as determined by the Investigator.
- Sustained (ie, 3 independent measurements within 30 minutes) HR (pulse) >100 or <40 bpm.
- Personal and/or family history of congenital long QT syndrome or sudden cardiac death.
- Pregnant (positive blood or urine pregnancy test at the initial screening visit or D-1).
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
- Unwilling to abstain from smoking or vaping and the consumption of any caffeine or alcohol-containing food or drinks that may influence the drug metabolism from 72 hours before administration to discharge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Neurodegenerative Diseases, Alzheimer's Disease
- Being tested
- SNP318 (A), Placebo (B)
- Medical subject headings
- Neurodegenerative Diseases, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNP318 (A)Drug
Capsule for oral administration
Placebo (B)Drug
Placebo capsules matching the SNP318 capsules
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Placebo (B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SNP318 in healthy adult participants. Assessed by adverse events
Measured: Up to 20 days
Secondary outcomes (7)
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Maximum concentration (Cmax)
Measured: Up to 20 days
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Time of maximum concentration observed (Tmax)
Measured: 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)
Measured: Up to 20 days
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Apparent oral clearance (CL/F)
Measured: Up to 20 days
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Apparent volume of distribution at steady state (Vss/F)
Measured: Up to 20 days
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Apparent terminal phase half-life (T1/2z)
Measured: Up to 20 days
The concentration of SNP318 in CSF samples in healthy adult participants
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start20 Mar 2023
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- SciNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792163
- Sponsor's protocol ID
- SNP318-101
- Status last verified
- Dec 2023
- First submitted
- 28 Feb 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05792163
- Acronym / sponsor ID
- SNP318-101
- Conditions
- Neurodegenerative Diseases, Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- SciNeuroIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (SNP318) | Experimental | Drug: SNP318 (A)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 |
| B (Placebo) | Placebo comparator | Drug: Placebo (B)Placebo comparator taken by participants randomized to the placebo arm in each cohort in Part 1 and Part 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (27 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNP318 (A)Capsule for oral administration | Drug | A (SNP318) |
| Placebo (B)Placebo capsules matching the SNP318 capsules | Drug | B (Placebo) |
Primary outcome
Safety and tolerability of SNP318 in healthy adult participants. Assessed by adverse events
Time frame: Up to 20 days
7 secondary outcomes
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Maximum concentration (Cmax)
Time frame: Up to 20 days
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Time of maximum concentration observed (Tmax)
Time frame: 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)
Time frame: Up to 20 days
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Apparent oral clearance (CL/F)
Time frame: Up to 20 days
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Apparent volume of distribution at steady state (Vss/F)
Time frame: Up to 20 days
Plasma PK parameters of SNP318 in healthy adult participants. Assessed by Apparent terminal phase half-life (T1/2z)
Time frame: Up to 20 days
The concentration of SNP318 in CSF samples in healthy adult participants
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNP318 (A) in people with Neurodegenerative Diseases and Alzheimer's Disease, run by SciNeuro at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of SNP318 in healthy adult participants. Assessed by adverse events (time frame: Up to 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.