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Minocin

Phase 4

Undisclosed | Small molecule | Other |CorMedix Inc.|Trials Updated: Dec 15, 2023

Minocin development status

Highest phase Phase 4 run by Derm Research @ 888 Inc. (NCT00240513)
Phase scored for CRMDPhase 1
Registered trials 15 across 13 sponsors since May 2007

Minocin target and mechanism

ModalitySmall molecule

Also known as Minocin (minocycline) for Injection, Minocycline

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment69

FDA Designations

No designations recorded

Minocin clinical trials

Minocin · 1 trial · 1 indication

Phase 1 1
NCT02802631Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Minocin (Minocycline) for Injection in Healthy AdultsNormal Healthy Volunteers
COMPLETED69 Analytics
PHASE1COMPLETED
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Minocin (Minocycline) for Injection in Healthy Adults
Normal Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Number Of Participants Experiencing Treatment-emergent Adverse Events
Day 1 through Day 17

Safety and tolerability of single and multiple intravenous doses of Minocin (minocycline) for Injection assessed by number of participants with adverse events.

Secondary Endpoints

Assessment of Area Under The Concentration-time Curve From Zero Hours To The Last Measured Concentration (AUC0-t) After A Single Dose Of Minocin On Day 1
Day 1 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing)
Assessment Of AUC0-t By Cohort After A Single Dose Of Minocin On Day 4
Day 4 (Measurements taken at 1 [end of infusion], 2, 4, 8, and 12 hours after the start of dosing)
Assessment Of AUC0-t By Cohort After Multiple Doses Of Minocin On Day 11
Day 11 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Minocin (minocycline) for InjectionEXPERIMENTALMinocin (minocycline) for Injection was supplied as a sterile lyophilized powder in single-use 10-milliliter (mL) glass vials. Each vial contained 108 milligrams (mg) of minocycline hydrochloride equivalent to 100 mg of minocycline. Each cohort received one of the following dosages of Minocin (minocycline) for Injection: 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, or 600 mg. Within each cohort, participants received a single dose on Day 1, followed by 7 days of multiple doses (Days 4 to 10, given every 12 hours), followed by a single dose on Day 11.
0.9% Sodium Chloride Injection USPPLACEBO_COMPARATORPlacebo was in the form of the same 100-mL bags of normal saline (0.9% Sodium Chloride Injection United States Pharmacopeia \[USP\]). Dosing was on the same schedule as participants randomized to Minocin (minocycline) for Injection.

Interventions

NameTypeDescription
Minocin (minocycline) for InjectionDRUGIntravenous formulation of minocycline, a derivative of tetracycline
PlaceboOTHERPlacebo - Normal Saline
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. A signed informed consent form, the ability to understand the study conduct and tasks that were required for study participation, and a willingness to cooperate with all tasks, tests, and examinations as required by the protocol, whether in the research unit or after discharg...

Countries:Netherlands
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Frequently asked questions about Minocin

What is Minocin?

Minocin is an injectable formulation of minocycline, a small molecule drug developed by CorMedix Inc. (ticker CRMD) under the name Minocin (minocycline) for Injection. It has been studied in a Phase 1 clinical trial in healthy adult volunteers.

Who makes Minocin?

Minocin is being developed by CorMedix Inc., which trades on the stock market under the ticker symbol CRMD. CorMedix is the company responsible for the development of Minocin (minocycline) for Injection.

What phase is Minocin in?

Minocin is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial has been completed.

What clinical trials is Minocin in?

Minocin has been studied in one completed Phase 1 clinical trial, NCT02802631, titled "Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Minocin (Minocycline) for Injection in Healthy Adults." The trial enrolled 69 healthy adult volunteers in the Netherlands and was randomized, double-blind, and placebo-controlled.

Is Minocin the same as Minocin (minocycline) for Injection?

Yes, Minocin is also known as Minocin (minocycline) for Injection. Both names refer to the same injectable formulation of minocycline developed by CorMedix Inc. (CRMD).