A Study of SYNT-101 to Test Safety, Tolerability and Pharmacodynamics of SYNT-101 in Healthy and Overweight Adults

Syntis Bio

Status and phase

Enrolling

Phase 1

Conditions

Healthy

Overweight and Obese Adults

Treatments

Drug: SYNT101

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07307274

SYNT101-001

Details and patient eligibility

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.

Enrollment

64 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.