A Study of SYNT-101 to Test Safety, Tolerability and Pharmacodynamics of SYNT-101 in Healthy and Overweight Adults
Recruiting · NCT07307274 · Interventional (participants receive a specific treatment) · Lead sponsor: Syntis Bio
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSYNT101
What this trial is about
A Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacodynamics of single and multiple dose regimens of SYNT-101 in healthy and overweight adults.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- Adult males and females, 18 to 55 years of age (inclusive) at screening.
- Medically healthy (in the opinion of the PI or delegate), as determined by pre-study medical history, and without clinically significant (CS) abnormalities.
- Have suitable venous access for blood sampling.
- Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Exclusion criteria
- Known hypersensitivity to the study drug or any of the study drug ingredients.
- History of anaphylaxis or other significant allergy which, in the opinion of the PI (or delegate), would interfere with the volunteer's ability to participate in the study.
- History or presence of CS cardiovascular, pulmonary, hepatic, renal, haematological, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months determined by the PI (or delegate) to be clinically relevant.
Where it is running
1 location listed.
- Veritus Research - Bayswater, Victoria, Australia