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

NImmune Biopharma

Status and phase: Completed; Phase 1

Conditions: Normal Healthy Volunteers

Treatments: Drug: Placebo; Drug: NIM-1324

Study type: Interventional

Funder types: Industry

Identifiers

NCT05019950

LABP-104-1a

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

NIM-1324

Experimental group

Description:

Once daily oral tablet

Treatment:

Drug: NIM-1324

Placebo

Placebo Comparator group

Description:

Once daily oral tablet

Treatment:

Drug: Placebo