A Study of NH280105 in Healthy Adult Participants

NCT06870058 | Completed Phase 1 DMC

• 1 other identifier: NH280105-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (4)

• Number of participants with adverse events following single and multiple adminstration of NH280105

  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.

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (2)

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.

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.

Drug: NH280105- MAD; Drug: Placebo

Interventions

NH280105- SAD DRUG

Dose formulation: Capsule Route of administration: oral

NH280105-SAD

NH280105- MAD DRUG

Dose formulation: Capsule Route of administration: oral

NH280105- MAD

Placebo DRUG

Matching placebo comparator

NH280105- MAD; NH280105-SAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Jiangsu Nhwa Pharmaceutical Co., Ltd.: lead

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Eric Sun

  Head of Global BD

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: March 12, 2025
• Primary Completion: November 13, 2025
• Study Completion: November 13, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)