Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers

Normal Healthy Volunteers Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Double-Blind, Single-Center Study to Evaluate Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05019950
• Other study ID #: LABP-104-1a
• Status: Completed
• Phase: Phase 1
• Start date: October 28, 2021
• Est. completion date: April 28, 2022

Study information

• Verified date: June 2023
• Source: NImmune Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The primary objective of this study is to assess the safety and tolerability of single and 7-day repeat oral doses NIM-1324 in healthy adult volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Key Inclusion Criteria:

1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects;

2. Adult males and females, 18 to 64 years of age (inclusive) at screening;

3. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Key Exclusion Criteria:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant;

2. Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications;

3. COVID-19: Testing positive for COVID-19, a current symptomatic infection within 20 days, or an asymptomatic infection within 6 weeks.

Related Conditions & MeSH terms

• Normal Healthy Volunteers

Intervention

Drug:
• NIM-1324
Once daily oral tablet
• Placebo
Once daily oral tablet

Locations

Country	Name	City	State
Australia	Clinical Site	Herston	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
NImmune Biopharma

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability		1 to 14 days
Secondary	PK		24 hours