A Study of SYNT-101 to Test Safety, Tolerability and Pharmacodynamics of SYNT-101 in Healthy and Overweight Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorSyntis Bio
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
SYNT101
DrugTablet
Placebo
DrugPlacebo tablet to match SYNT101 in appearance.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Active Drug SYNT101Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety Evaluation
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.
Time frame
From enrolment up to 7 days post dosing in the SAD and up to 36 days post dosing in the MAD.Secondary outcomes
1
Area under the plasma concentration versus time curve (AUC) after single SYNT101 dose
Evaluate the pharmacokinetics (Area Under the Plasma Concentration Curve) of SYNT101 after a single dose via measuring concentration levels in the blood.
Time frame
At Pre-dose, 1 hr , 3 hr, 4 hr, 8 hr, 12 hr, 24 hours post-dose.2
Area under the plasma concentration versus time curve (AUC) after multiple SYNT101 doses.
Evaluate the pharmacokinetics (Area Under the Plasma Concentration Curve) of SYNT101 after multiple doses via measuring concentration levels in the blood.
Time frame
At Pre-Dose, 1 hr , 3 hr, 4 hr, 8 hr, 12 hr, 24 hours post-dose. Source ClinicalTrials.gov