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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
NHL907
DrugInvestigational product NHL907
Placebo
DrugNHL907 matching placebo
Treatment groups
64 Participants
are divided into 16 treatment groups16
Treatment groupsSee each treatment group below.
Group A: NHL907 Dose 1Experimental treatment 1 intervention
Group B: NHL907 Dose 2Experimental treatment 1 intervention
Group C: NHL907 Dose 3Experimental treatment 1 intervention
Group D: NHL907 Dose 4Experimental treatment 1 intervention
Group E: NHL907 Dose 5Experimental treatment 1 intervention
Group F: NHL907 Dose 6Experimental treatment 1 intervention
Group G: NHL907 Dose 7Experimental treatment 1 intervention
Group H: NHL907 Dose 8Experimental treatment 1 intervention
Group I: Placebo Dose 1Placebo comparator 1 intervention
Group J: Placebo Dose 2Placebo comparator 1 intervention
Group K: Placebo Dose 3Placebo comparator 1 intervention
Group L: Placebo Dose 4Placebo comparator 1 intervention
Group M: Placebo Dose 5Placebo comparator 1 intervention
Group N: Placebo Dose 6Placebo comparator 1 intervention
Group O: Placebo Dose 7Placebo comparator 1 intervention
Group P: Placebo Dose 8Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Treatment Emergent Adverse Events
Time frame
Baseline to 7 days after the last dose (Day 14)Secondary outcomes
1
Cmax: Maximum observed plasma concentration
Time frame
Day 1, Day 72
Tmax: Time of occurrence of Cmax
Time frame
Day 1, Day 73
AUC0-24: Area under the concentration-time curve from 0 to 24 hours
Time frame
Day 1, Day 74
AUC0-inf: Area under the concentration-time curve from 0 to infinity
Time frame
Day 1, Day 7Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NeuHyll AUS Pty Ltd
Lead sponsor
NeuHyll Therapeutics Inc
Collaborator
Source ClinicalTrials.gov