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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03993704 | Multiple Ascending Oral Dose 14-Day Trial of LHF-535 in Healthy Participants | PHASE1 | COMPLETED | 24 | — | — | Sep 16, 2019 | Jun 9, 2020 | Jul 9, 2020 | 1 | Australia |
Safety and tolerability
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | 450 mg, 1125 mg, or 2250 mg of LHF-535 given once daily for 14 days |
| Placebo | PLACEBO_COMPARATOR | Placebo to match LHF-535 given once daily for 14 days |
| Name | Type | Description |
|---|---|---|
| LHF-535 | DRUG | Oral suspension administered once daily for 14 days |
Inclusion Criteria: * Male or female 18 to 50 years of age, inclusive, at the time of screening * Able to understand the requirements of the study, to provide written informed consent (as evidenced by signature on an informed consent document that is approved by a Human Research Ethics Committee \[...