GSM-779690T for Healthy Adults
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of a new treatment called GSM-779690T in healthy adults. The study consists of two parts: one where participants receive a single dose and another where they receive multiple doses. Researchers aim to determine the treatment's safety and its effects on specific proteins related to brain health. Eligible participants should be healthy adults who feel cognitively typical and can remain at the clinic for required procedures. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any current medications, as the trial prohibits the use of any concomitant medications, except for prescribed birth control methods. However, older participants in Cohort 10 may be allowed to continue a stable dose regimen of certain medications if approved by the Medical Monitor.
Is there any evidence suggesting that GSM-779690T is likely to be safe for humans?
Research has shown that GSM-779690T is undergoing its first human trials to assess safety. The treatment's tolerability in people remains unknown. As an early-stage trial, the primary goal is to evaluate how participants tolerate GSM-779690T. Researchers will closely monitor participants for any side effects. Participants will receive varying doses to determine the safe amount. As a Phase 1 trial, this marks the first human testing of the treatment, with safety as the main focus.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about GSM-779690T because it offers a potential new approach for enhancing health and well-being in healthy adults. Unlike traditional treatments that might focus on disease management, this treatment is being explored for its effects in a healthy population. GSM-779690T might have a unique mechanism of action or delivery method that distinguishes it from current options, though specific details are still under investigation. Its potential to benefit healthy individuals makes it an intriguing candidate to explore further.
What evidence suggests that GSM-779690T could be effective?
Research is investigating how GSM-779690T affects certain proteins related to Alzheimer's disease. The treatment targets Aβ peptide isoforms, proteins that can form plaques in the brain, a key feature of Alzheimer's. By altering these proteins, the drug aims to address the disease's underlying causes. Although this treatment is new and limited information exists from human studies, the trial's main goal is to assess its effects on these proteins in healthy individuals. Participants in the various treatment arms will receive different dosages to ensure safety and observe any changes in protein levels, guiding future research.23678
Who Is on the Research Team?
Doug Galasko, MD
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
This trial is for healthy adults, including older adults in one cohort, who are interested in participating in a study to test GSM-779690T, a new potential treatment for Alzheimer's disease. Participants must meet all screening requirements and provide informed consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Ascending Dose (SAD)
Participants receive a single oral dose of GSM-779690T at increasing strengths or placebo
Multiple Ascending Dose (MAD)
Participants receive multiple oral doses of GSM-779690T, informed by SAD data
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GSM-779690T
Find a Clinic Near You
Who Is Running the Clinical Trial?
Acta Pharmaceuticals, Inc
Lead Sponsor