MedTrace Logo

A Trial in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated

NCT04866160 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-13

No results posted yet for this study

Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male and female subjects following administration of multiple rising doses over 4 weeks and to explore the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1291583 after multiple dosing and assess the PK/PD relationship.

Conditions

  • Healthy

Interventions

DRUG

BI 1291583

BI 1291583

DRUG

Placebo

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • Germany

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 NCT04866160 on ClinicalTrials.gov