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

June 6, 2023 updated by: NImmune Biopharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) and a multiple ascending dose (MAD) part (Part B). A total of 56 participants will be randomized in this study (35 in the SAD part, 21 in the MAD part).

SAD Part: Participants will be randomized to receive a single oral dose of LABP-104 (250 mg, 500 mg, 750 mg, 1000 mg or 1500 mg) or placebo after a 6-hour fast.

MAD Part: Participants will be randomized to receive LABP-104 (250 mg, 750 mg, or 1500 mg) or placebo once daily for 7 days after a 6-hour fast.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIM-1324
Once daily oral tablet
Drug: NIM-1324
Once daily oral tablet
Placebo Comparator: Placebo
Once daily oral tablet
Drug: Placebo
Once daily oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability
Time Frame: 1 to 14 days
1 to 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
PK
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NImmune Biopharma

Investigators

  • Study Director: Simon Lichtiger, MD, Landos Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2021

Primary Completion (Actual)

April 28, 2022

Study Completion (Actual)

April 28, 2022

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LABP-104-1a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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