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Recruiting Phase 1 NCT07307274

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.
Locations 1
Australia (1)
Veritus Research
Bayswater , Victoria
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
No
Start date
05.01.2026
Completion date
31.12.2026
Registry ID
NCT07307274
Source
anzctr
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