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Single Dose and Multiple Dose Study to Assess Safety and Tolerability of LOU064

NCT03918980 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2021-10-12

No results posted yet for this study

Summary

This is a 6-part first-in-human study in up to approximately 184 participants. Parts 1 to 5 is in health volunteers and part 6 is in subjects with atopic dermatitis.

The purpose of this first-in-human study is to assess the safety and tolerability and pharmacokinetics (PK) of single and multiple doses of LOU064 both as once and twice daily oral administration in healthy volunteers and those with atopic diathesis or atopic dermatitis. This study will also explore the effect of food intake and different drug substance particle sizes on the in vivo disposition of LOU064 in healthy volunteers to guide dosing and formulation development for future clinical trials.

The study is registered on CT.Gov with the initiation of part 6 in patients (FPFV in April 2019).

Conditions

  • Healthy Volunteers, Atopic Diathesis and Atopic Dermatitis

Interventions

DRUG

LOU064

LOU064 will be administered as oral capsules in parts 1 to 6.

DRUG

Placebo

Matching placebo capsules will be administered in parts 1,2, 4 and 6.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-18
Primary Completion
2020-01-27
Completion
2020-01-27

Countries

  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03918980 on ClinicalTrials.gov