A Study of NH280105 in Healthy Adult Participants (NCT06870058) | Clinical Trial Compass
CompletedPhase 1
A Study of NH280105 in Healthy Adult Participants
Australia32 participantsStarted 2025-03-12
Plain-language summary
This is a Phase 1, randomized, double-blinded, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NH280105 in healthy volunteers. In addition, this study will evaluate the effects of food on NH280105 under a two-period study setting.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged ≥ 18 years at the time of informed consent.
. At the discretion of the PI or designee, in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before the first administration of IP.
. Body mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 50 kg.
. Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee.
. Not pregnant or breastfeeding, or willing to cease breastfeeding.
. Woman of childbearing potential or fertile man agrees to use an acceptable method of contraception from the start of Screening until 90 days after the last dose of IP. Acceptable methods of contraception are defined in protocol.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events following single and multiple adminstration of NH280105
Timeframe: SAD- Up to Day 8; SAD FE- Up to Day 22; MAD- Up to Day 21 post first dose administration
2
Number of participants with change in laboratory parameters following treatment administration.
Timeframe: SAD- Up to Day 8; SAD FE- Up to Day 22; MAD- Up to Day 21 post first dose administration
3
Number of participants with change in vital sign measurements following treatment adminstration
Timeframe: SAD- Up to Day 8; SAD FE- Up to Day 22; MAD- Up to Day 21 post first dose administration
4
Number of participants with change in physical examination following treatment administration
Timeframe: SAD- Up to Day 8; SAD FE- Up to Day 22; MAD- Up to Day 21 post first dose administration
. Males must be surgically sterile (\> 30 days since vasectomy with no viable sperm) or, if engaged in sexual relations with a WOCBP, must agree to use an acceptable contraceptive method.
. Females or males with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle.
Exclusion criteria
. Use of tobacco or nicotine products exceeding 5 cigarettes (or equivalent) per week in any form within 30 days prior to IP administration on Day 1, or unwillingness to refrain from smoking, vaping, or using any nicotine products for at least 96 hours before the first IP administration, the onfinement period, and any Follow-up Visits.
. Underlying physical or psychological medical condition that, in the opinion of the PI or designee, would make the participant unlikely to comply with the protocol or complete the study per protocol.
. Blood or plasma donation or had significant blood loss (400 mL) within 30 days prior to the first administration of IP.
. Fever (body temperature \> 37.5°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening.
. Infections requiring parenteral antibiotics within 6 months prior to Screening.
. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), human immunodeficiency virus (HIV) antibody.
. Positive pregnancy test at Screening and/or on Day -1.
. History of life-threatening infection (eg, meningitis).