Alzheimer DiseasePhase 1NCT06870058
A Study of NH280105 in Healthy Adult Participants
A Phase 1 study testing NH280105- SAD and NH280105- MAD in people with Alzheimer Disease, run by Jiangsu Nhwa Pharmaceutical Co., Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- NH280105- SAD and NH280105- MAD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Mar 2025to 13 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- Notes:
- 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.
- Males must not donate sperm from the first dose of IP until at least 90 days after the last dose of IP.
- Able and willing to attend the necessary visits to the study site.
- Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
Who cannot join
- 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.
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- Positive pregnancy test at Screening and/or on Day -1.
- History of life-threatening infection (eg, meningitis).
- Receiving live vaccine within 30 days prior to IP administration on Day 1 or require receiving live vaccination during the study or within 30 days end of the study.
- Poor pill swallowing ability / poor venous access.
- History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents; exceptions might be granted on a case-by-case basis upon agreement of the PI and the Sponsor.
- History of malignancy, except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
- Abnormal cardiac conditions and/or ECG findings at Screening
- The Fridericia algorithm corrected QT interval (QTcF) of ECG during Screening Period is > 450 msec for males and > 470 msec for females or is considered abnormal with clinical significance as determined by the PI or designee.
- Sustained (ie, 3 independent measurements within 30 minutes) heart rate (HR) > 100 or < 45 bpm.
- Personal and/or family history of congenital long QT syndrome or sudden cardiac death.
- BP is greater than 140/90 mmHg or below 90/40 mmHg and are considered by the PI/designee to be clinically significant.
- History immunological disorders, auto-immune disorders, acquired or congenital immune deficiency, including autoimmune rheumatic disease.
- Note: participants with mild asthma controlled with occasional rescue inhaler only (no chronic therapy; no inhaled corticosteroids), and mild atopic dermatitis controlled with topic emollients only (no topical corticosteroids) are not excluded.
- Exposure to any drugs that cause significant immunosuppression (including experimental therapies as part of a clinical study) within 4 months or 5 elimination half-lives (whichever is longer), prior to Screening.
- Clinically significant abnormalities in laboratory test, including, including alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) > 1.5 × upper limit of normal (ULN) at Screening. Repeat testing at Screening is acceptable for out-of-range values following approval by the PI/designee.
- Positive toxicology screening panel (urine test including qualitative identification of methamphetamine, opiates, cocaine, tetrahydrocannabinol (THC), pphencyclidine, benzodiazepines, barbiturates, methadone, tricyclic antidepressants (TCAs), amphetamine), nicotine (NB: positive nicotine is only exclusionary on Day -1, not during the screening period leading up to Day -1), and/or alcohol breath test at Screening or Day -1.
- History of substance abuse or dependency or history of recreational IV drug use over the last 12 months (by self-declaration).
- Regular alcohol consumption defined as > 10 standard drinks per week (where 1 standard drink = 360 mL of beer, 45 mL of 40% spirit or a 150 mL glass of wine) or > 4 standard drinks on any single day.
- Unwilling to refrain from alcohol, methylxanthines, poppy seeds, and caffeine and caffeine consumption starting 48 hours before admission to the study site, throughout the confinement period, and for 48 hours prior to sequential dosing and any Follow-up Visits.
- Use of any investigational medical device or investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the first administration of the IP.
- Use of (or anticipated use of) any prescription drugs (other than hormonal contraception; oral contraceptive pills, long-acting implantable hormones, injectable hormones, a vaginal ring, or an intrauterine device [IUD]) within 30 days, OTC medication, nonsteroidal anti-inflammatory drug (NSAID), herbal remedies, supplements or vitamins within 14 days or 5 elimination half-lives (whichever is longer) prior to the first administration of IP and during the course of the study without prior approval of the PI and Sponsor MM. Simple analgesia (paracetamol) or other agents may be permitted at the discretion of the PI. Exception: Women of childbearing potential (WOCBP) are permitted to use hormonal contraception.
- Unwilling to refrain from strenuous exercise (including weightlifting) from 48 hours prior to admission to the study site and from 48 hours prior to any Follow-up Visits.
- Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
- Anything that the PI considers would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.
- Consumption of any known liver enzyme inducers or inhibitors, including foods or beverages such as citrus fruits (eg, tangerines, grapefruits, sweet oranges, limes, kumquats, citrons, oranges, lemons, etc.) and their juices, is prohibited within 7 days prior to the first administration of the IP.
- Any major surgery within 6 months before Screening, or plan to have a surgery during the study. Participants meeting the following criterion are excluded from Part 1 - Cohort 3 (Food-effect Cohort).
- Inability or unwillingness to consume a standard high-fat meal, as described in FDA Guidance for fed vs. fasted PK studies.
Trial locations and contacts
1 site in 1 country.
Australia1 site
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose of Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NH280105 in Healthy Adult Participants
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.
Read the detailed description
This study will be conducted in 2 parts: Part 1 (SAD) and Part 2 (MAD). Approximately 48 participants will be enrolled.
- Part 1 (Cohorts 1, 2, and 4): The study design includes a double-blind, placebo-controlled setting for SAD cohorts.
- Part 1 (Cohort 3): This cohort will be a double-blind, placebo-controlled, two-conditions (ie, fed vs. fasted), two-period, crossover setting for the Food-effect Cohort.
- Part 2: The study design includes a double-blind, placebo-controlled setting for MAD cohorts.
Oversight will be provided by a Safety Review Committee (SRC). Safety, tolerability, and PK/PD data (if available) of the preceding dose levels in both Part 1 (SAD) and Part 2 (MAD) will be reviewed by the SRC for dose escalation and the actual doses to be administered may be adjusted accordingly.
- Conditions
- Alzheimer Disease
- Being tested
- NH280105- SAD, NH280105- MAD, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NH280105- SADDrug
Dose formulation: Capsule Route of administration: oral
NH280105- MADDrug
Dose formulation: Capsule Route of administration: oral
PlaceboDrug
Matching placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| NH280105-SAD | Experimental | SAD: Participants will either receive NH280105 or placebo across 4 cohorts
* Cohorts 1, 2 and 4: Single dose on Day 1.
* Cohort 3: Single dose on Days 1 and 15. Receives: Drug: NH280105- SAD; Drug: Placebo |
| NH280105- MAD | Experimental | MAD: Participants will receive either NH280105 or placebo, once daily for 14 days across 2-3 cohorts. Receives: Drug: NH280105- MAD; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events following single and multiple adminstration of NH280105
Measured: SAD- Up to Day 8; SAD FE- Up to Day 22; MAD- Up to Day 21 post first dose administration
Number of participants with change in laboratory parameters following treatment administration.
Hematology, clinical chemistry, coagulation and urinalysis will be assessed.
Measured: SAD- Up to Day 8; SAD FE- Up to Day 22; MAD- Up to Day 21 post first dose administration
Number of participants with change in vital sign measurements following treatment adminstration
Blood pressure, heart rate, body temperature and respiratory rate will be assessed
Measured: SAD- Up to Day 8; SAD FE- Up to Day 22; MAD- Up to Day 21 post first dose administration
Number of participants with change in physical examination following treatment administration
Measured: SAD- Up to Day 8; SAD FE- Up to Day 22; MAD- Up to Day 21 post first dose administration
Secondary outcomes (13)
Plasma PK Parameters- Maximum plasma concentration (Cmax) for SAD and MAD cohorts
Measured: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters-Time for maximum plasma concentration (Tmax) for SAD and MAD cohorts
Measured: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters-Delay between the time of dosing and time of appearance of concentration (Tlag) for SAD and MAD cohorts
Measured: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters-Area Under Curve for SAD and MAD cohorts
Measured: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters-Elimination half-life (t1/2) for SAD and MAD cohorts
Measured: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters- Elimination rate constant (Kel) for SAD and MAD cohorts
Measured: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters-Volume of distribution (Vz/F) for SAD and MAD cohorts
Measured: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters- Clearance per bioavailability (CL/F) for SAD and MAD cohorts
Measured: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters- Mean Residence time (MRT) for SAD and MAD cohorts
Measured: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
To evaluate the PD effect of repeated oral doses of NH280105 on the plasma Lp-PLA2 inhibition from baseline
Measured: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK: The ratio of fed/fasted on Cmax- Maximum plasma concentration
Measured: Part 1 - Food effect Cohort (Cohort 3) From Day 1 to Day 19 except Day 14.
Plasma PK: The ratio of fed/fasted on AUC(0-t)- Area under curve from 0 to timepoint
Measured: Part 1 - Food effect Cohort (Cohort 3) From Day 1 to Day 19 except Day 14.
Plasma PK: The ratio of fed/fasted on AUC(0-inf)- Area under curve from 0 to infinity
Measured: Part 1 - Food effect Cohort (Cohort 3) From Day 1 to Day 19 except Day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start12 Mar 2025
- Primary completion13 Nov 2025
- Study completion13 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sun, Study director, Head of Global BD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870058
- Sponsor's protocol ID
- NH280105-101
- Status last verified
- Jan 2026
- First submitted
- 5 Mar 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose of Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NH280105 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06870058
- Acronym / sponsor ID
- NH280105-101
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 11 Mar 2025 (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.
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.
Detailed description
This study will be conducted in 2 parts: Part 1 (SAD) and Part 2 (MAD). Approximately 48 participants will be enrolled.
- Part 1 (Cohorts 1, 2, and 4): The study design includes a double-blind, placebo-controlled setting for SAD cohorts.
- Part 1 (Cohort 3): This cohort will be a double-blind, placebo-controlled, two-conditions (ie, fed vs. fasted), two-period, crossover setting for the Food-effect Cohort.
- Part 2: The study design includes a double-blind, placebo-controlled setting for MAD cohorts.
Oversight will be provided by a Safety Review Committee (SRC). Safety, tolerability, and PK/PD data (if available) of the preceding dose levels in both Part 1 (SAD) and Part 2 (MAD) will be reviewed by the SRC for dose escalation and the actual doses to be administered may be adjusted accordingly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NH280105-SAD | Experimental | Drug: NH280105- SAD, Drug: PlaceboSAD: Participants will either receive NH280105 or placebo across 4 cohorts * Cohorts 1, 2 and 4: Single dose on Day 1. * Cohort 3: Single dose on Days 1 and 15. |
| NH280105- MAD | Experimental | Drug: NH280105- MAD, Drug: PlaceboMAD: Participants will receive either NH280105 or placebo, once daily for 14 days across 2-3 cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (33 listed)
- 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.
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 |
|---|---|---|
| NH280105- SADDose formulation: Capsule Route of administration: oral | Drug | NH280105-SAD |
| NH280105- MADDose formulation: Capsule Route of administration: oral | Drug | NH280105- MAD |
| PlaceboMatching placebo comparator | Drug | NH280105- MAD, NH280105-SAD |
Primary outcome
Number of participants with adverse events following single and multiple adminstration of NH280105
Time frame: SAD- Up to Day 8; SAD FE- Up to Day 22; MAD- Up to Day 21 post first dose administration
Number of participants with change in laboratory parameters following treatment administration.
Time frame: SAD- Up to Day 8; SAD FE- Up to Day 22; MAD- Up to Day 21 post first dose administration
Hematology, clinical chemistry, coagulation and urinalysis will be assessed.
Number of participants with change in vital sign measurements following treatment adminstration
Time frame: SAD- Up to Day 8; SAD FE- Up to Day 22; MAD- Up to Day 21 post first dose administration
Blood pressure, heart rate, body temperature and respiratory rate will be assessed
Number of participants with change in physical examination following treatment administration
Time frame: SAD- Up to Day 8; SAD FE- Up to Day 22; MAD- Up to Day 21 post first dose administration
13 secondary outcomes
Plasma PK Parameters- Maximum plasma concentration (Cmax) for SAD and MAD cohorts
Time frame: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters-Time for maximum plasma concentration (Tmax) for SAD and MAD cohorts
Time frame: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters-Delay between the time of dosing and time of appearance of concentration (Tlag) for SAD and MAD cohorts
Time frame: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters-Area Under Curve for SAD and MAD cohorts
Time frame: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters-Elimination half-life (t1/2) for SAD and MAD cohorts
Time frame: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters- Elimination rate constant (Kel) for SAD and MAD cohorts
Time frame: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters-Volume of distribution (Vz/F) for SAD and MAD cohorts
Time frame: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters- Clearance per bioavailability (CL/F) for SAD and MAD cohorts
Time frame: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK Parameters- Mean Residence time (MRT) for SAD and MAD cohorts
Time frame: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
To evaluate the PD effect of repeated oral doses of NH280105 on the plasma Lp-PLA2 inhibition from baseline
Time frame: SAD- From Day 1 to Day 5; SAD FE- Day 1 to Day 5 and Day 15 to day 19; MAD- Day 1, Day2, Day3, Day 5, day 8, day 12, day 14, day 15, day 16, day 17and Day 18 post dose adminstration
Plasma PK: The ratio of fed/fasted on Cmax- Maximum plasma concentration
Time frame: Part 1 - Food effect Cohort (Cohort 3) From Day 1 to Day 19 except Day 14.
Plasma PK: The ratio of fed/fasted on AUC(0-t)- Area under curve from 0 to timepoint
Time frame: Part 1 - Food effect Cohort (Cohort 3) From Day 1 to Day 19 except Day 14.
Plasma PK: The ratio of fed/fasted on AUC(0-inf)- Area under curve from 0 to infinity
Time frame: Part 1 - Food effect Cohort (Cohort 3) From Day 1 to Day 19 except Day 14.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 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. This study is not recruiting at the moment.
Eric Sun study director
Head of Global BD
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 NH280105- SAD and NH280105- MAD in people with Alzheimer Disease, run by Jiangsu Nhwa Pharmaceutical Co., 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 12 inclusion and 33 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: finished, as of the sponsor's last update on 15 Jan 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events following single and multiple adminstration of NH280105 (time frame: SAD- Up to Day 8; SAD FE- Up to Day 22; MAD- Up to Day 21 post first dose administration). The study lists 4 primary outcomes in all. 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 15 Jan 2026.