Trials / Terminated
TerminatedNCT05199142
A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline
A Phase 1b, Exploratory, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Syndesi Therapeutics · Industry
- Sex
- All
- Age
- 65 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, double-blind, randomized, placebo-controlled study to determine the safety, tolerability, and pharmacodynamics of SDI-118 in a once daily (QD) dosing regimen on elderly male and female study participants with cognitive decline at screening.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SDI-118 | SDI-118 Powder in Capsules (PiC) are presented as Drug Substance in white, size 3, hydroxypropylmethylcellulose (HPMC) capsules. No excipients are added. |
| DRUG | Placebo | The Matching Placebo for SDI-118 PiC is equivalent dose of mannitol (an inert excipient) in white, size 3, hydroxypropylmethylcellulose (HPMC) capsules. |
Timeline
- Start date
- 2021-09-23
- Primary completion
- 2022-03-11
- Completion
- 2022-03-11
- First posted
- 2022-01-20
- Last updated
- 2022-04-22
Locations
2 sites across 2 countries: Germany, United Kingdom
Source: ClinicalTrials.gov record NCT05199142. Inclusion in this directory is not an endorsement.