Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ha44 Gel, Abametapir Lotion
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 being developed for the treatment of head lice infestation, also known as pediculosis. It is a small molecule therapeutic candidate studied as a topical gel applied under maximal use conditions. Dr. Reddy's Laboratories Ltd is developing the asset, which has completed Phase 2 clinical testing in patients with head lice infestation.
Ha44 is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the clinical program evaluating Ha44 Gel for head lice infestation and pediculosis. No partnership or licensing arrangement for the asset has been disclosed.
Ha44 has completed Phase 2 clinical development. A Phase 2 safety and pharmacokinetic study of Ha44 Gel under maximal use conditions has been completed, and an earlier Phase 1 electrocardiogram study in healthy volunteers has also finished. The drug is investigational and is not approved for commercial use.
Ha44 has been studied in two completed trials. NCT01907490 was a Phase 2 safety and pharmacokinetic study of Ha44 Gel under maximal use conditions for head lice infestation, enrolling 38 participants. NCT01518699 was a Phase 1 study evaluating the effect of Ha44 Gel on the electrocardiogram in 57 healthy volunteers in the United States.
Yes, Ha44 Gel is the formulation name used for Ha44, the topical gel product studied in clinical trials. Both names refer to the same investigational asset developed by Dr. Reddy's Laboratories Ltd for head lice infestation and pediculosis. Searches for either name point to the same development program.
Ha44 Gel has been studied in participants as young as 6 months of age in the Phase 2 head lice trial, which enrolled both male and female subjects. The Phase 1 electrocardiogram study enrolled healthy adult volunteers aged 18 years and older. The drug remains investigational and has not been approved for any patient population.