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A Study of NP-011 in Healthy Volunteers

NCT05387499 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-08-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

NP-011 (Single Ascending Dose Phase)

The participants will receive assigned single dose of NP-011 after a minimum 8 hour fast on Day 1

DRUG

NP-011 (Multiple Ascending Dose Phase)

The participants will receive assigned dose of NP-011 after a minimum 8 hour fast once daily for 7 days

OTHER

NP-011 (Placebo)

The participants will receive single dose of NP-011 after a minimum 8 hour fast on Day 1 in Single Ascending Dose part and will receive once daily for 7 days after a minimum 8 hour fast in Multiple Ascending dose part of the study

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Nexel Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jessica Gehlert · CMAX Clinical Research Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2023-03-07
Completion
2023-05-26

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387499 on ClinicalTrials.gov