NCT02802631

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics of Minocin® (Minocycline) for Injection in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this study was to collect safety, tolerability, and pharmacokinetic (PK) data on ascending dose regimens of Minocin (minocycline) for Injection. The safety, tolerability, and PK data was to support the compound as a potential clinical candidate in Europe and allow recommendations of dose levels to be used in future Phase 2/3 studies.

Conditions

• Normal Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Minocin (minocycline) for Injection	Intravenous formulation of minocycline, a derivative of tetracycline
OTHER	Placebo	Placebo - Normal Saline

Timeline

• Start date: 2017-04-20
• Primary completion: 2018-02-08
• Completion: 2018-02-08
• First posted: 2016-06-16
• Last updated: 2023-12-15
• Results posted: 2023-05-09

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study