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

NCT ID: NCT07307274

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-05

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Overweight and Obese Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active Drug SYNT101

Group Type ACTIVE_COMPARATOR

SYNT101

Intervention Type DRUG

Tablet

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet to match SYNT101 in appearance.

Interventions

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SYNT101

Tablet

Intervention Type DRUG

Placebo

Placebo tablet to match SYNT101 in appearance.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Syntis Bio

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Veritus Research

Bayswater, Victoria, Australia

Site Status

Countries

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Australia

Facility Contacts

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Rebecca Wolf

Role: primary

Other Identifiers

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SYNT101-001

Identifier Type: -

Identifier Source: org_study_id