A Study of NHL907 in Healthy Adult Participants
ConditionHealthy Adult Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNeuHyll AUS Pty Ltd
About this trial
The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of NHL907 when administered as multiple oral doses in healthy adult participants.
Eligibility criteria
Qualifiers
Healthy adult male and female participants aged between 18 and 60 years of age, inclusive.
Has a body mass index (BMI) between ≥ 18 and ≤ 32 kg/m2 inclusive, with body weight ≥ 50 kg at Screening.
Able and willing to understand and sign the informed consent form, communicate meaningfully with study personnel, and comply with all study restrictions, procedures, laboratory tests, and other study requirements.
In good health, determined by the Investigator on the basis of medical history, physical examination, vital signs, Screening laboratory results, Screening ECG, and mental status.
Disqualifiers
History or evidence of clinically significant disorders and deemed not suitable to participants in the study by the Principal Investigator or delegate.
History or presence of any gastrointestinal (GI) disease (except for Gilbert's syndrome or cholecystectomy) or condition that could compromise the participant safety and/or absorption of the study drug, including irritable bowel disease, known untreated helicobacter pylori infection, abnormal gastric emptying, dyspepsia, GI ulcers, GI bleeding, or GI surgeries within 6 months before Screening.
Have a known hypersensitivity to any component of the IP formulation or related derivatives of each component.
Have abnormalities in resting vital signs at Screening, on Day -1, or on Day 1 prior to dosing.
Trial design
Treatments tested in this trial
- NHL907
- Placebo
Treatment groups
64 Participants
are divided into 16 treatment groups16
Treatment groupsSee each treatment group below.
Sponsors and collaborators
NeuHyll AUS Pty Ltd
Lead sponsor
NeuHyll Therapeutics Inc
Collaborator
Source ClinicalTrials.gov