Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Minocin · 1 trial · 1 indication
Safety and tolerability of single and multiple intravenous doses of Minocin (minocycline) for Injection assessed by number of participants with adverse events.
| Arm | Type | Description |
|---|---|---|
| Minocin (minocycline) for Injection | EXPERIMENTAL | Minocin (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 USP | PLACEBO_COMPARATOR | Placebo 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. |
| Name | Type | Description |
|---|---|---|
| Minocin (minocycline) for Injection | DRUG | Intravenous formulation of minocycline, a derivative of tetracycline |
| Placebo | OTHER | Placebo - Normal Saline |
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...
Minocin is a small molecule drug being studied for use in normal healthy volunteers. It is currently in Phase 1 clinical development as an investigational therapy. The drug is being evaluated for safety, tolerability, and pharmacokinetics in healthy adults.
Minocin is being developed by CorMedix Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol CRMD. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetic profile in healthy volunteers.
Minocin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
Minocin has one completed Phase 1 clinical trial registered under NCT02802631. The study evaluated the safety, tolerability, and pharmacokinetics of Minocin (minocycline) for injection in healthy adults. The trial enrolled 69 participants and was conducted in the Netherlands.
Minocin is a brand name for minocycline, an antibiotic. In clinical trials, it is referred to as Minocin (minocycline) for injection. The drug is being studied for its safety and pharmacokinetic profile in healthy volunteers.