A Study of NHL907 in Healthy Adult Participants

NCT07580924 | Not Yet Recruiting Phase 1

• 1 other identifier: NHL907-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult Participants

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment Emergent Adverse Events

  Baseline to 7 days after the last dose (Day 14)

Secondary Outcomes (12)

• Cmax: Maximum observed plasma concentration

  Day 1, Day 7

• Tmax: Time of occurrence of Cmax

  Day 1, Day 7

• AUC0-24: Area under the concentration-time curve from 0 to 24 hours

  Day 1, Day 7

• AUC0-inf: Area under the concentration-time curve from 0 to infinity

  Day 1, Day 7

• Cmax/dose: Cmax normalized by dose

  Day 1, Day 7

Study Arms (16)

NHL907 Dose 1

EXPERIMENTAL

NHL907 Dose 1

Drug: NHL907

NHL907 Dose 2

EXPERIMENTAL

NHL907 Dose 2

Drug: NHL907

NHL907 Dose 3

EXPERIMENTAL

NHL907 Dose 3

Drug: NHL907

NHL907 Dose 4

EXPERIMENTAL

NHL907 Dose 4

Drug: NHL907

NHL907 Dose 5

EXPERIMENTAL

NHL907 Dose 5

Drug: NHL907

NHL907 Dose 6

EXPERIMENTAL

NHL907 Dose 6

Drug: NHL907

NHL907 Dose 7

EXPERIMENTAL

NHL907 Dose 7

Drug: NHL907

NHL907 Dose 8

EXPERIMENTAL

NHL907 Dose 8

Drug: NHL907

Placebo Dose 1

PLACEBO COMPARATOR

Placebo for Dose 1

Drug: Placebo

Placebo Dose 2

PLACEBO COMPARATOR

Placebo for Dose 2

Drug: Placebo

Placebo Dose 3

PLACEBO COMPARATOR

Placebo for Dose 3

Drug: Placebo

Placebo Dose 4

PLACEBO COMPARATOR

Placebo for Dose 4

Drug: Placebo

Placebo Dose 5

PLACEBO COMPARATOR

Placebo for Dose 5

Drug: Placebo

Placebo Dose 6

PLACEBO COMPARATOR

Placebo for Dose 6

Drug: Placebo

Placebo Dose 7

PLACEBO COMPARATOR

Placebo for Dose 7

Drug: Placebo

Placebo Dose 8

PLACEBO COMPARATOR

Placebo for Dose 8

Drug: Placebo

Interventions

NHL907 DRUG

Investigational product NHL907

NHL907 Dose 1; NHL907 Dose 2; NHL907 Dose 3; NHL907 Dose 4; NHL907 Dose 5; NHL907 Dose 6; NHL907 Dose 7; NHL907 Dose 8

Placebo DRUG

NHL907 matching placebo

Placebo Dose 1; Placebo Dose 2; Placebo Dose 3; Placebo Dose 4; Placebo Dose 5; Placebo Dose 6; Placebo Dose 7; Placebo Dose 8

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• NeuHyll AUS Pty Ltd: lead
• NeuHyll Therapeutics Inc: collaborator

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Location

Central Study Contacts

James Connell, MD

CONTACT

+61 (0)8 7088 7900; james.connell@cmax.com.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)