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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05597462 | Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks | PHASE1 | COMPLETED | 60 | — | — | Sep 30, 2022 | May 30, 2023 | Aug 2, 2023 | 2 | United States |
Change in the colony forming units (CFUs) of microbial species colonized from skin, gastrointestinal or vaginal swabs from Baseline (BL) to Week 16 in comparison of DFD-29 versus Placebo treatment groups
Changes in MIC90 of the selected colonized microbial species to minocycline in the comparison of DFD-29 group versus Placebo treatment groups.
| Arm | Type | Description |
|---|---|---|
| DFD-29 | EXPERIMENTAL | DFD-29 (minocycline hydrochloride) capsules, 40 mg will be administered orally once daily for 16 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules will be administered orally once daily for 16 weeks. |
| Name | Type | Description |
|---|---|---|
| Minocycline hydrochloride capsules | DRUG | Minocycline hydrochloride capsules, 40 mg will be administered orally once daily for 16 weeks. |
| Placebo | OTHER | Placebo capsules will be administered orally once daily for 16 weeks. |
Inclusion Criteria: 1. Male or non-pregnant, non-lactating female aged ≥ 18 and ≤ 65 years. 2. Subjects must have understood, and signed IRB/IEC approved written ICF. 3. Subjects must be willing to refrain from using all other antibiotics during the 16-week treatment period, other than the IP. 4. W...