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First-In-Human Study of Apramycin

NCT04105205 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-02-23

No results posted yet for this study

Summary

This is a first-in-human study to assess the safety, tolerability and pharmacokinetics of escalating single doses of apramycin. This trial will be conducted as a single ascending dose trial in up to 5 sequential dose cohorts (group-comparison). Each cohort will consist of 8 healthy subjects, 6 will receive apramycin and 2 placebo.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Apramycin injection

30-min infusion

DRUG

Placebo injection

30-min infusion

Sponsors & Collaborators

  • Innovative Medicines Initiative

    collaborator OTHER

  • Juvabis AG

    lead INDUSTRY

Principal Investigators

  • Armin Schultz, Dr.med. · CRS Clinical Research Services Mannheim GmbH

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-09-25
Primary Completion
2020-07-16
Completion
2020-10-16

Countries

  • Germany

Study Locations

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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 NCT04105205 on ClinicalTrials.gov