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
Qualifiers
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
Treatments tested in this trial
- SYNT101
- Placebo
Treatment groups
64 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov