Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02802631 | Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Minocin (Minocycline) for Injection in Healthy Adults | PHASE1 | COMPLETED | 69 | — | — | Apr 20, 2017 | Feb 8, 2018 | Dec 15, 2023 | 1 | Netherlands |
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...