TBD11 Safety Study in Healthy Adults
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a randomized, double-blind, placebo controlled First in human (FIH) trial of TBD11, administered to healthy adults. The trial will be conducted in two parts. Part 1 will consist of single ascending dose (SAD) and Food effect (FE) cohorts, and Part 2 will consist of multiple ascending dose (MAD) cohorts.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy adults, it's possible that taking certain medications might affect eligibility. Please consult with the trial staff for specific guidance.
Are You a Good Fit for This Trial?
This trial is for healthy adults who can participate in a study to test the safety and behavior of a new substance called TBD11. Specific eligibility details are not provided, but typically participants must meet certain health standards.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 single ascending doses of TBD11 or placebo
Food Effect (FE) and Bioequivalence (BE)
Open-label evaluation of food effect and alternative formulation of TBD11
Multiple Ascending Dose (MAD)
Participants receive multiple ascending doses of TBD11 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TBD11
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bill & Melinda Gates Medical Research Institute
Lead Sponsor
Gates Medical Research Institute
Lead Sponsor