Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ha44 · 2 trials · 2 indications
Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.
The primary endpoint is the difference between the active (HA44) and placebo for time matched baseline adjusted mean QTcF = \[ΔQTcF (Ha44 0.74% Gel) - ΔQTcF (placebo)\] = ΔΔQTcF. This was compared with the difference between Moxifloxacin and placebo for time matched baseline adjusted mean QTcF = \[ΔQTcF (Moxifloxacin) - ΔQTcF (placebo)\] = ΔΔQTcF
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Ha44 Gel 0.74%, topical solution, maximum feasible amount applied for 10 minutes |
| HA44 Abametapir Lotion | EXPERIMENTAL | Study drug plus positive-control placebo. |
| Placebo | PLACEBO_COMPARATOR | Placebo plus positive-control placebo. |
| Moxifloxacin | ACTIVE_COMPARATOR | Placebo plus positive control |
| Name | Type | Description |
|---|---|---|
| Ha44 Gel | DRUG | Eligible subjects will be treated at the study site on Day 0 with a single application of the maximum feasible amount of Ha44 Gel, to ensure saturation of the scalp and hair. |
| Ha44 | DRUG | Abametapir Lotion 0.74% |
| Ha44 Placebo | DRUG | Ha44 Vehicle Gel without Abametapir |
| Moxifloxacin Placebo | DRUG | Moxifloxacin Placebo |
| Moxifloxacin | DRUG | Moxifloxacin 400mg |
Inclusion Criteria: 1. Male or female 2. 6 months to 17 years of age 3. Be in good health, as determined by medical history and physical examination 4. Has an active head lice infestation at screening as determined by an experienced evaluator. An active infestation is defined as the presence of at ...
Ha44 is an investigational small molecule being developed for the treatment of head lice infestation and pediculosis. It is formulated as a gel and is currently in clinical development, having completed Phase 2 trials.
Ha44 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY.
Ha44 is in Phase 2 of clinical development. It has completed a Phase 2 safety and pharmacokinetics study under maximal use conditions for the treatment of head lice infestation.
Ha44 has been studied in two completed clinical trials: NCT01518699, a Phase 1 study evaluating the effect of Ha44 gel on the electrocardiogram in healthy volunteers, and NCT01907490, a Phase 2 safety and PK study under maximal use conditions for head lice infestation.
Ha44 is not FDA approved. It is an investigational drug that has completed clinical trials but has not yet received regulatory approval for marketing.