A Study of SYNT-101 to Test Safety, Tolerability and Pharmacodynamics of SYNT-101 in Healthy and Overweight Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SYNT101, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy, Overweight and Obese Adults. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Interventions
- Drug SYNT101
Tablet - Drug Placebo
Placebo tablet to match SYNT101 in appearance.
Primary outcome measures
- Safety Evaluation [Time frame: From enrolment up to 7 days post dosing in the SAD and up to 36 days post dosing in the MAD.]
Secondary outcome measures (2)
- Area under the plasma concentration versus time curve (AUC) after single SYNT101 dose [Time frame: At Pre-dose, 1 hr , 3 hr, 4 hr, 8 hr, 12 hr, 24 hours post-dose.]
- Area under the plasma concentration versus time curve (AUC) after multiple SYNT101 doses. [Time frame: At Pre-Dose, 1 hr , 3 hr, 4 hr, 8 hr, 12 hr, 24 hours post-dose.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Veritus Research — Bayswater
Identifiers
NCT: NCT07307274 · SYNT101-001