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Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Minocin (Minocycline) for Injection in Healthy Adults

NCT02802631 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2023-12-15

Study results available
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Summary

This was a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study of the safety, tolerability, and pharmacokinetics of Minocin (minocycline) for injection in healthy adult participants.

Conditions

  • Normal Healthy Volunteers

Interventions

DRUG

Minocin (minocycline) for Injection

Intravenous formulation of minocycline, a derivative of tetracycline

OTHER

Placebo

Placebo - Normal Saline

Sponsors & Collaborators

  • Universitätsklinikum Köln

    collaborator OTHER

  • Innovative Medicines Initiative

    collaborator OTHER

  • Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)

    lead INDUSTRY

Principal Investigators

  • Dr. Naguib Muhsen, MD · QPS Holdings LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2018-02-08
Completion
2018-02-08
FDA Drug
Yes

Countries

  • Netherlands

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 NCT02802631 on ClinicalTrials.gov