Healthy, Overweight and Obese Adults
Conditions
Brief 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.
Interventions
DRUGSYNT101
Tablet
DRUGPlacebo
Placebo tablet to match SYNT101 in appearance.
Sponsors
Syntis Bio
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluation | From enrolment up to 7 days post dosing in the SAD, up to 36 days post dosing in the MAD. | The Number of participants with Adverse Events, with abnormal Vital Signs, abnormal Physical Examination findings, abnormal Laboratory Tests results, abnormal 12-lead Electrocardiogram (ECG) readings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) after single SYNT101 dose | At Pre-dose, 1 hr , 3 hr, 4 hr, 8 hr, 12 hr, 24 hours post-dose. | Evaluate the pharmacokinetics (Area Under the Plasma Concentration Curve) of SYNT101 after a single dose via measuring concentration levels in the blood. |
| Area under the plasma concentration versus time curve (AUC) after multiple SYNT101 doses. | At Pre-Dose, 1 hr , 3 hr, 4 hr, 8 hr, 12 hr, 24 hours post-dose. | Evaluate the pharmacokinetics (Area Under the Plasma Concentration Curve) of SYNT101 after multiple doses via measuring concentration levels in the blood. |
Countries
Australia
Outcome results
None listed