A Study of SYNT-101 to Test Safety, Tolerability and Pharmacodynamics of SYNT-101 in Healthy and Overweight Adults
Phase 1 – testing safety in a small group of people
Conditions:
Healthy
Overweight and Obese Adults
Sponsor: Syntis Bio
trial.available_in:
БГ
Overview
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 participate
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.