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

NCT05019950 | Completed Phase 1 FDA Drug

• 1 other identifier: LABP-104-1a
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Normal Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  1 to 14 days

Secondary Outcomes (1)

• PK

  24 hours

Study Arms (2)

NIM-1324

EXPERIMENTAL

Once daily oral tablet

Drug: NIM-1324

Placebo

PLACEBO COMPARATOR

Once daily oral tablet

Drug: Placebo

Interventions

NIM-1324 DRUG

Once daily oral tablet

NIM-1324

Placebo DRUG

Once daily oral tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Adult males and females, 18 to 64 years of age (inclusive) at screening;
• Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

You may not qualify if:

• 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;
• Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications;
• COVID-19: Testing positive for COVID-19, a current symptomatic infection within 20 days, or an asymptomatic infection within 6 weeks.

Sponsors & Collaborators

• NImmune Biopharma: lead

Study Sites (1)

Clinical Site

Herston, Queensland, 4006, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 25, 2021
• Study Start: October 28, 2021
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)