Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LHF-535 · 1 trial · 1 indication
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 \[...
LHF-535 is an investigational small molecule developed by TuHURA Biosciences, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition it is intended to treat has not been publicly disclosed, so its therapeutic use is not yet defined.
LHF-535 is being developed by TuHURA Biosciences, Inc., which trades on the Nasdaq under the ticker HURA. The company sponsored the Phase 1 trial of the compound conducted in Australia.
LHF-535 is in Phase 1 development. A single Phase 1 trial has been completed, and no trials are currently active. The compound has not been approved by the FDA and remains investigational.
LHF-535 was evaluated in one Phase 1 trial, NCT03993704, titled Multiple Ascending Oral Dose 14-Day Trial of LHF-535 in Healthy Participants. The trial enrolled 24 healthy adults in Australia, was randomized, double-blind, and placebo-controlled, and has been completed.
The Phase 1 trial NCT03993704 was a randomized, double-blind, placebo-controlled multiple ascending oral dose study. It ran for 14 days and enrolled 24 healthy participants aged 18 years and older in Australia. The trial has been completed.