Actively Recruiting
A Phase 1 Randomised, Double-blind, Placebo-controlled Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYNT-101 in Healthy and Overweight Adults
Led by Syntis Bio · Updated on 2026-04-29
64
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1 study to evaluate the safety, tolerability, and pharmacodynamics of SYNT-101, a drug being studied in healthy and overweight adults aged 18 to 55. This randomized, double-blind, placebo-controlled trial aims to understand how the drug behaves in the body and its safety profile. The study is sponsored by Syntis Bio and focuses on initial human testing to gather important information about SYNT-101. Participants will receive either SYNT-101 tablets or matching placebo tablets in single ascending doses and multiple ascending doses. The study involves carefully controlled dosing schedules to monitor how the drug is processed in the body over time. Both single and repeated doses will be tested to assess safety and drug levels in the blood. During the study, participants will undergo safety evaluations from enrollment through up to 36 days after dosing, including monitoring for adverse effects. Blood samples will be collected at multiple time points after dosing to measure drug concentration and pharmacokinetics. Volunteers will be asked to comply with all study assessments and follow the protocol throughout the trial, which includes frequent visits and monitoring by the research team.
CONDITIONS
Brief Title
A Study of SYNT-101 to Test Safety, Tolerability and Pharmacodynamics of SYNT-101 in Healthy and Overweight Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must understand the study purpose, risks, and effects
- Adults aged 18 to 55 years at screening
- Medically healthy without significant abnormalities
- Have suitable veins for blood sampling
- Willing and able to follow study assessments and schedule
You will not qualify if you...
- Known allergy to SYNT-101 or its ingredients
- History of severe allergy or anaphylaxis affecting study participation
- History or presence of significant cardiovascular, lung, liver, kidney, blood, hormone, immune, skin, psychiatric, or neurological diseases within past 3 months considered relevant by study doctor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 days post dosing
Participants receive single and multiple doses of SYNT-101 or placebo to evaluate safety, tolerability, and pharmacodynamics.
Multiple visits for dosing and assessments over treatment period
Duration - Up to 36 days post dosing
Participants are monitored for safety and pharmacodynamic effects after dosing.
Visits at 1 hr, 3 hr, 4 hr, 8 hr, 12 hr, and 24 hr post-dose for assessments
Trial Site Locations
Total: 1 location
1
Veritus Research
Bayswater, Victoria, Australia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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