A Study of SYNT-101 to Test Safety, Tolerability and Pharmacodynamics of SYNT-101 in Healthy and Overweight Adults

August 24, 2026 updated by: Syntis Bio

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Bayswater, Victoria, Australia
        • Veritus Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo tablet to match SYNT101 in appearance.
Active Comparator: Active Drug SYNT101
Drug: SYNT101
Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Evaluation
Time Frame: 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.
From enrolment up to 7 days post dosing in the SAD, up to 36 days post dosing in the MAD.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Evaluate the pharmacokinetics (Area Under the Plasma Concentration Curve) of SYNT101 after a single dose via measuring concentration levels in the blood.
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.
Evaluate the pharmacokinetics (Area Under the Plasma Concentration Curve) of SYNT101 after multiple doses via measuring concentration levels in the blood.
At Pre-Dose, 1 hr , 3 hr, 4 hr, 8 hr, 12 hr, 24 hours post-dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syntis Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2026

Primary Completion (Actual)

July 14, 2026

Study Completion (Actual)

July 14, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

December 14, 2025

First Posted (Actual)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYNT101-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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