SYNT-101 safety and dosing in healthy and overweight adults
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
This trial will test whether single and repeated doses of SYNT-101 are safe and produce measurable biological effects in healthy and overweight adults aged 18–55.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Syntis Bio Industry-sponsored |
| Locations | 1 site (Bayswater, Victoria) |
| Trial ID | NCT07307274 on ClinicalTrials.gov |
What this trial studies
This Phase 1, single-center, randomized, double-blind, placebo-controlled trial gives single and multiple doses of SYNT-101 to healthy and overweight adults to track safety, tolerability, and pharmacodynamic responses. Participants will be screened to confirm they are medically healthy and have suitable venous access for blood sampling. Volunteers will be randomized to receive SYNT-101 or placebo and followed with clinical assessments and laboratory tests over the dosing and follow-up periods. The results will be used to identify safe dose ranges and early biological signals to guide later clinical development.
Who should consider this trial
Good fit: Adults aged 18–55 who are medically healthy or overweight, have suitable venous access, and can comply with study procedures and visits are ideal candidates.
Not a fit: People with significant cardiovascular, pulmonary, hepatic, renal, hematologic, endocrine, immune, psychiatric, or neurological disease, those with known hypersensitivity to the drug, pregnant people, or those outside the 18–55 age range are unlikely to benefit from this Phase 1 safety-focused trial.
Why it matters
Potential benefit: If successful, the trial could identify safe dosing and early biological effects of SYNT-101 to support future development for overweight and obesity treatment.
How similar studies have performed: Randomized, double-blind, placebo-controlled Phase 1 trials are the standard approach for first-in-human safety and pharmacodynamic testing; SYNT-101 itself is a novel agent that has not yet been proven effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bayswater, Victoria
- Veritus Research — Bayswater, Victoria, Australia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.