Healthy Adult ParticipantsPhase 1NCT07580924
A Study of NHL907 in Healthy Adult Participants
A Phase 1 study testing NHL907 in people with Healthy Adult Participants, run by NeuHyll AUS Pty Ltd at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- NHL907
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 12 May 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Participants of non-childbearing potential should be congenitally or surgically sterile or in a menopausal state as confirmed by follicle-stimulating hormone (FSH) concentrations (≥ 40 IU/L at Screening).
- Female participants with childbearing potential must agree to use accepted contraceptive regimens from time of Screening, during the study, and for at least 60 days after end of study.
- Male participants with the potential to father a child must agree to abstain from sperm donation and to use accepted contraceptive regimens from Screening, during the study, and for at least 90 days after end of study.
- Participants should agree to refrain from donating blood for at least 30 days after end of study.
Who cannot join
- If an individual meets any of the following criteria, they will be ineligible for this study:
- 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.
- History of or ongoing cardiac abnormalities as assessed during Screening, including abnormal and clinically relevant ECG changes, considered by the Investigator.
Show all 29Show fewer
- History of smoking in the past 90 days before Screening which is defined as more than the equivalent of 5 cigarettes weekly (including alternative nicotine products such as cigars, e-cigarettes, chewing tobacco, etc.); and /or have a positive urine test for cotinine at Screening or Baseline, or unable to abstain from smoking starting from at least 3 days before Screening, or Day -1 / check-in until end of study.
- History of illicit or prescription drug abuse or addiction within 1 year of Screening, or positive urine drug screen at Screening or Baseline. Participants who used a THC / CBD product within 30 days before Screening and added a deterrent from any use before that are excluded.
- History of alcohol abuse (unless fully recovered with no use of alcohol within the 12 months prior to Screening), which is defined as exceeding an average weekly intake of 21 standard drinks for males or 14 standard drinks for females (1 standard drink is equivalent to 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor); or positive alcohol breath test at Screening or Baseline; incapable to refrain from consuming alcohol starting from at least 48 h prior to Day 1 / check-in until end of study.
- Has participated in any interventional trial or drug investigation or device investigation (including placebo) within 30 days, or 5 half-lives of the IP, whichever is longer, prior to Screening or has the intention to participate in another trial during the present study.
- Have received vaccines within 14 days and within 60 days for live-attenuated vaccines before screening.
- Have any medical condition(s) screened by the Investigator and determined to be ineligible or have any acute illness within 7 days prior to Day 1 will be excluded or may be considered for the next cohort if still within their screening window.
- Have clinical safety laboratory parameters at Screening (serum chemistry and lipid panel, hematology, coagulation, and urinalysis) that are outside the normal limits and are considered clinically significant in the opinion of the Investigator and the Sponsor's MM (e.g., LFTs / bilirubin ≥ 1.5 ULN and eGFR ≤ 60 ml/min/1.73 m2). Participants with elevated unconjugated bilirubin (Gilbert's syndrome) are not excluded.
- History of suicidal ideations or suicide attempts, including current instances of either case or any "yes" response to C-SSRS at screening.
- The participant is pregnant, lactating, or planning to become pregnant within 6 months of being discharged from the trial.
- Use of any prescription medicine within 2 weeks, or over the counter (OTC) medicine, herbal remedy, or nutritional supplement, or within 5 half-lives of any drugs, whichever is longer prior to dosing, except for vitamins and occasional use of paracetamol / acetaminophen (≤ 2 g/day; no more than 3 consecutive days) which will be reviewed by the PI and the Sponsor's MM for determination of acceptability.
- Have undergone surgery within 90 days before Screening, or have surgery planned during the study period or within 90 days after the last dose or has previously undergone any surgery that may affect drug absorption, distribution, metabolism, or excretion during the study.
- Blood donation or loss of ≥ 450 mL of blood within 90 days before dosing or receiving a blood transfusion within 90 days before dosing. Platelet/Plasma donation is prohibited within 30 days before Screening and until at least 30 days after study completion.
- Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-1 and HIV-2), or syphilis at Screening.
- History of malignancy, with the exception of non-melanoma skin cancer or curatively treated cancer that has not been in full remission for ≥ 5 years, without evidence of recurrence.
- Have any special dietary requirements that may include CYP2D6 inhibitors, e.g., grapefruit, bitter citrus products, tonic water, or any other requirement that would prevent compliance with study standardized meals.
- History of dysphagia or difficulty swallowing tablets / capsules.
- Unable or unwilling to comply with the lifestyle guidelines and evaluations detailed in this protocol, for the duration of the study or have a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.
- Participants who cannot perform venous blood sampling (i.e., poor venous access or vasovagal response to injection).
- Any other circumstances or laboratory abnormalities that, in the Investigator's judgement, may result in an unacceptable increase in risk to the participant, or impair the participant's ability to participate in and complete the study, or could preclude the evaluation of the participant's response.
- Have any clinically significant abnormality on physical examination at Screening, on Day -1, or on Day 1 prior to dosing which in the opinion of the Investigator would exclude them from the study.
- History of a severe allergic reaction to any drug or multiple food / drug allergies.
- Heavy caffeine drinker (> 5 cups or glasses of caffeinated beverages, e.g., coffee, tea, cola per day).
- Have any condition which, in the judgement of the Investigator, would prevent the participant from completing the study or complying with study procedures and requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
James Connell, MD, +61 (0)8 7088 7900, cmax@cmax.com.au
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of NHL907 Combination Drug Following Multiple Oral Doses in Healthy Adult Participants
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.
- Conditions
- Healthy Adult Participants
- Being tested
- NHL907, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NHL907Drug
Investigational product NHL907
PlaceboDrug
NHL907 matching placebo
| Study group | Role | What they receive |
|---|---|---|
| NHL907 Dose 1 | Experimental | NHL907 Dose 1 Receives: Drug: NHL907 |
| NHL907 Dose 2 | Experimental | NHL907 Dose 2 Receives: Drug: NHL907 |
| NHL907 Dose 3 | Experimental | NHL907 Dose 3 Receives: Drug: NHL907 |
| NHL907 Dose 4 | Experimental | NHL907 Dose 4 Receives: Drug: NHL907 |
| NHL907 Dose 5 | Experimental | NHL907 Dose 5 Receives: Drug: NHL907 |
| NHL907 Dose 6 | Experimental | NHL907 Dose 6 Receives: Drug: NHL907 |
| NHL907 Dose 7 | Experimental | NHL907 Dose 7 Receives: Drug: NHL907 |
| NHL907 Dose 8 | Experimental | NHL907 Dose 8 Receives: Drug: NHL907 |
| Placebo Dose 1 | Placebo comparator | Placebo for Dose 1 Receives: Drug: Placebo |
| Placebo Dose 2 | Placebo comparator | Placebo for Dose 2 Receives: Drug: Placebo |
| Placebo Dose 3 | Placebo comparator | Placebo for Dose 3 Receives: Drug: Placebo |
| Placebo Dose 4 | Placebo comparator | Placebo for Dose 4 Receives: Drug: Placebo |
| Placebo Dose 5 | Placebo comparator | Placebo for Dose 5 Receives: Drug: Placebo |
| Placebo Dose 6 | Placebo comparator | Placebo for Dose 6 Receives: Drug: Placebo |
| Placebo Dose 7 | Placebo comparator | Placebo for Dose 7 Receives: Drug: Placebo |
| Placebo Dose 8 | Placebo comparator | Placebo for Dose 8 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events
Measured: Baseline to 7 days after the last dose (Day 14)
Secondary outcomes (12)
Cmax: Maximum observed plasma concentration
Measured: Day 1, Day 7
Tmax: Time of occurrence of Cmax
Measured: Day 1, Day 7
AUC0-24: Area under the concentration-time curve from 0 to 24 hours
Measured: Day 1, Day 7
AUC0-inf: Area under the concentration-time curve from 0 to infinity
Measured: Day 1, Day 7
Cmax/dose: Cmax normalized by dose
Measured: Day 1, Day 7
CL/F: Apparent total clearance
Measured: Day 1, Day 7
Vz/F: Apparent volume of distribution
Measured: Day 1, Day 7
AUC0-24/dose: AUC0-24 normalized by dose
Measured: Day 1, Day 7
AUC0-inf/dose: AUC0-inf normalized by dose
Measured: Day 1, Day 7
t1/2: Apparent terminal elimination half-life
Measured: Day 1, Day 7
Ctrough: Trough plasma concentration
Measured: Day 4-7
RA Cmax: Observed accumulation ratio based on Cmax
Measured: Day 7 to Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start12 May 2026
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuHyll AUS Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NeuHyll Therapeutics Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580924
- Sponsor's protocol ID
- NHL907-101
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of NHL907 Combination Drug Following Multiple Oral Doses in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07580924
- Acronym / sponsor ID
- NHL907-101
- Conditions
- Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- NeuHyll AUS Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- NeuHyll Therapeutics Inc
- Study start
- 12 May 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| NHL907 Dose 1 | Experimental | Drug: NHL907NHL907 Dose 1 |
| NHL907 Dose 2 | Experimental | Drug: NHL907NHL907 Dose 2 |
| NHL907 Dose 3 | Experimental | Drug: NHL907NHL907 Dose 3 |
| NHL907 Dose 4 | Experimental | Drug: NHL907NHL907 Dose 4 |
| NHL907 Dose 5 | Experimental | Drug: NHL907NHL907 Dose 5 |
| NHL907 Dose 6 | Experimental | Drug: NHL907NHL907 Dose 6 |
| NHL907 Dose 7 | Experimental | Drug: NHL907NHL907 Dose 7 |
| NHL907 Dose 8 | Experimental | Drug: NHL907NHL907 Dose 8 |
| Placebo Dose 1 | Placebo comparator | Drug: PlaceboPlacebo for Dose 1 |
| Placebo Dose 2 | Placebo comparator | Drug: PlaceboPlacebo for Dose 2 |
| Placebo Dose 3 | Placebo comparator | Drug: PlaceboPlacebo for Dose 3 |
| Placebo Dose 4 | Placebo comparator | Drug: PlaceboPlacebo for Dose 4 |
| Placebo Dose 5 | Placebo comparator | Drug: PlaceboPlacebo for Dose 5 |
| Placebo Dose 6 | Placebo comparator | Drug: PlaceboPlacebo for Dose 6 |
| Placebo Dose 7 | Placebo comparator | Drug: PlaceboPlacebo for Dose 7 |
| Placebo Dose 8 | Placebo comparator | Drug: PlaceboPlacebo for Dose 8 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
- Participants of non-childbearing potential should be congenitally or surgically sterile or in a menopausal state as confirmed by follicle-stimulating hormone (FSH) concentrations (≥ 40 IU/L at Screening).
Key exclusion criteria (29 listed)
- If an individual meets any of the following criteria, they will be ineligible for this study:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NHL907Investigational product NHL907 | Drug | NHL907 Dose 1, NHL907 Dose 2, NHL907 Dose 3, NHL907 Dose 4, NHL907 Dose 5, NHL907 Dose 6, NHL907 Dose 7, NHL907 Dose 8 |
| PlaceboNHL907 matching placebo | Drug | Placebo Dose 1, Placebo Dose 2, Placebo Dose 3, Placebo Dose 4, Placebo Dose 5, Placebo Dose 6, Placebo Dose 7, Placebo Dose 8 |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events
Time frame: Baseline to 7 days after the last dose (Day 14)
12 secondary outcomes
Cmax: Maximum observed plasma concentration
Time frame: Day 1, Day 7
Tmax: Time of occurrence of Cmax
Time frame: Day 1, Day 7
AUC0-24: Area under the concentration-time curve from 0 to 24 hours
Time frame: Day 1, Day 7
AUC0-inf: Area under the concentration-time curve from 0 to infinity
Time frame: Day 1, Day 7
Cmax/dose: Cmax normalized by dose
Time frame: Day 1, Day 7
CL/F: Apparent total clearance
Time frame: Day 1, Day 7
Vz/F: Apparent volume of distribution
Time frame: Day 1, Day 7
AUC0-24/dose: AUC0-24 normalized by dose
Time frame: Day 1, Day 7
AUC0-inf/dose: AUC0-inf normalized by dose
Time frame: Day 1, Day 7
t1/2: Apparent terminal elimination half-life
Time frame: Day 1, Day 7
Ctrough: Trough plasma concentration
Time frame: Day 4-7
RA Cmax: Observed accumulation ratio based on Cmax
Time frame: Day 7 to Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NHL907 in people with Healthy Adult Participants, run by NeuHyll AUS Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Connell, MD (+61 (0)8 7088 7900, james.connell@cmax.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (time frame: Baseline to 7 days after the last dose (Day 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.