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RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

SYNT101

Tablet

DRUG

Placebo

Placebo tablet to match SYNT101 in appearance.

Locations (1)

Veritus Research
Bayswater, Victoria, Australia