Trials / Completed
CompletedNCT05792163
A First Time in Human Study of SNP318 as a Treatment for Neurodegenerative Diseases Including Alzheimer's Disease
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- SciNeuro · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SNP318 (A) | Capsule for oral administration |
| DRUG | Placebo (B) | Placebo capsules matching the SNP318 capsules |
Timeline
- Start date
- 2023-03-20
- Primary completion
- 2023-11-29
- Completion
- 2023-11-29
- First posted
- 2023-03-31
- Last updated
- 2023-12-15
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT05792163. Inclusion in this directory is not an endorsement.