NCT06870058

A Study of NH280105 in Healthy Adult Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Jiangsu Nhwa Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	NH280105- SAD	Dose formulation: Capsule Route of administration: oral
DRUG	NH280105- MAD	Dose formulation: Capsule Route of administration: oral
DRUG	Placebo	Matching placebo comparator

Timeline

• Start date: 2025-03-12
• Primary completion: 2025-11-13
• Completion: 2025-11-13
• First posted: 2025-03-11
• Last updated: 2026-01-15

Locations

1 site across 1 country: Australia