Jiangsu Nhwa Pharmaceutical Co., Ltd. · Interventional, Randomized
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.
Full record on ClinicalTrials.gov (NCT ID NCT06870058).
| Endpoint | Type | Result | Significance |
|---|---|---|---|
| Number of participants with adverse events following single and multiple adminstration of NH280105 | Primary | None | None |
| Number of participants with change in laboratory parameters following treatment administration. | Primary | None | None |
| Number of participants with change in vital sign measurements following treatment adminstration | Primary | None | None |
| Number of participants with change in physical examination following treatment administration | Primary | None | None |
| Plasma PK Parameters- Maximum plasma concentration (Cmax) for SAD and MAD cohorts | Secondary | None | None |
| Plasma PK Parameters-Time for maximum plasma concentration (Tmax) for SAD and MAD cohorts | Secondary | None | None |
| Plasma PK Parameters-Delay between the time of dosing and time of appearance of concentration (Tlag) for SAD and MAD cohorts | Secondary | None | None |
| Plasma PK Parameters-Area Under Curve for SAD and MAD cohorts | Secondary | None | None |
| Plasma PK Parameters-Elimination half-life (t1/2) for SAD and MAD cohorts | Secondary | None | None |
| Plasma PK Parameters- Elimination rate constant (Kel) for SAD and MAD cohorts | Secondary | None | None |
| Plasma PK Parameters-Volume of distribution (Vz/F) for SAD and MAD cohorts | Secondary | None | None |
| Plasma PK Parameters- Clearance per bioavailability (CL/F) for SAD and MAD cohorts | Secondary | None | None |
| Plasma PK Parameters- Mean Residence time (MRT) for SAD and MAD cohorts | Secondary | None | None |
| To evaluate the PD effect of repeated oral doses of NH280105 on the plasma Lp-PLA2 inhibition from baseline | Secondary | None | None |
| Plasma PK: The ratio of fed/fasted on Cmax- Maximum plasma concentration | Secondary | None | None |
| Plasma PK: The ratio of fed/fasted on AUC(0-t)- Area under curve from 0 to timepoint | Secondary | None | None |
| Plasma PK: The ratio of fed/fasted on AUC(0-inf)- Area under curve from 0 to infinity | Secondary | None | None |
Full results record on ClinicalTrials.gov.
Age range: ≥ 18 · Sex: All · Healthy volunteers: Accepts
1 site participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.