RecruitingPhase 1NCT07307274

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

A Phase 1 Randomised, Double-blind, Placebo-controlled Single Ascending and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYNT-101 in Healthy Adults and Healthy Adults Who Are Overweight or Have Obesity

Sponsor

Syntis Bio

Enrollment

64 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Overweight and Obese Adults

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria5

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 Criteria3

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.

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Interventions

DRUGSYNT101

Tablet

DRUGPlacebo

Placebo tablet to match SYNT101 in appearance.

Locations(1)

Veritus Research

Bayswater, Victoria, Australia

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NCT07307274

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