A Study of NP-011 in Healthy Volunteers

Status Completed

Clinical Trial Summary

This is a Phase 1, randomised, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetic of NP-011 in healthy volunteers.

Clinical Trial Description

NP-011 is a truncated form of human MFG-E8 recombinant protein. NP-011 placebo has an identical formulation to the NP-011 drug product, prepared without the active pharmaceutical ingredient. The study will be conducted in 2 parts: Single Ascending Dose (SAD): The participants will be randomized to receive NP-011 (n= 6 per cohort) or placebo (n= 2 per cohort) on Day 1. For all Part 1 cohorts, 2 sentinel participants will receive the first dose of IP (1 to receive NP-011, 1 to receive placebo) on Day 1. If dosing of the sentinel participants proceeds without clinically significant adverse events over 24 hours, the remaining participants in the cohort will be dosed at the discretion of the Principal Investigator (PI), according to the randomization schedule. There are total five cohorts in Part 1 Cohort 1A: NP-011 250 μg or placebo (6:2) Cohort 1B: NP-011 500 μg or placebo (6:2) Cohort 1C: NP-011 1000 μg or placebo (6:2) Cohort 1D: NP-011 2000 μg or placebo (6:2) Cohort 1E: NP-011 4000 μg or placebo (6:2) Multiple Ascending Dose (MAD): The part 2 progress after the completion of Day 8 assessments in Cohort 1E upon satisfactory review of all available safety data by the SMC. Participants will be enrolled into 3 sequential cohorts in Part 2. Dose levels for Part 2 cohorts may be revised by agreement with the SMC and based on emerging safety and PK data. Cohort 2A: NP-011 1000 μg or placebo (6:2) Cohort 2B: NP-011 2000 μg or placebo (6:2) Cohort 2C: NP-011 4000 μg or placebo (6:2) The participants will be randomized to receive the NP-011 (n= 6 per cohort) or placebo (n=2 per cohort) The safety and pharmacokinetic data will be reviewed by SMC in both the parts (SAD and MAD) prior to the decision to increase or decrease the dose level for the next cohort or expand the number of participants in a cohort (to a maximum of an additional 8 participants at a given dose level). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05387499
Study type	Interventional
Source	Nexel Co., Ltd.
Contact
Status	Completed
Phase	Phase 1
Start date	June 10, 2022
Completion date	May 26, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06013813` - Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI	N/A
Completed	`NCT04507529` - Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients	N/A
Recruiting	`NCT06066970` - Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
Recruiting	`NCT03620266` - Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI	N/A
Completed	`NCT04097912` - Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
Completed	`NCT04153006` - Comparison of Fingerstick Versus Venous Sample for Troponin I.
Completed	`NCT03668587` - Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement
Recruiting	`NCT01218776` - International Survey of Acute Coronary Syndromes in Transitional Countries
Completed	`NCT03076801` - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?	N/A
Recruiting	`NCT05371470` - Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation	N/A
Recruiting	`NCT04562272` - Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP	N/A
Completed	`NCT04584645` - A Digital Flu Intervention for People With Cardiovascular Conditions	N/A
Active, not recruiting	`NCT04475380` - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Not yet recruiting	`NCT06007950` - Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health	N/A
Withdrawn	`NCT05327855` - Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)	Phase 2
Recruiting	`NCT02876952` - High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients	N/A
Completed	`NCT02711631` - Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation	N/A
Completed	`NCT02917213` - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed	`NCT02305602` - A Study of VentriGel in Post-MI Patients	Phase 1
Completed	`NCT02382731` - Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction	N/A