Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers
- Registration Number
- NCT05019950
- Lead Sponsor
- NImmune Biopharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
- 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.
Key
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NIM-1324 NIM-1324 Once daily oral tablet Placebo Placebo Once daily oral tablet
- Primary Outcome Measures
Name Time Method Safety and Tolerability 1 to 14 days
- Secondary Outcome Measures
Name Time Method PK 24 hours
Trial Locations
- Locations (1)
Clinical Site
🇦🇺Herston, Queensland, Australia