Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 3, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectiveness, safety, and tolerability of ZP5-9676 compared to placebo for the treatment of STH infections. Approximately 300 participants will be enrolled, randomized at the Baseline visit (Day 1) to one of the following treatments in a 1:1 ratio of active and placebo.
Approximately 300 infected participants will be enrolled to ensure that there is a minimum of 114 hookworm-infected participants evaluable for the Test of Cure study visit (Day 14). Some participants may be co-infected and will be included in each tally.
Participants will be randomized (1:1) to one of the treatments below followed by standard of care treatment:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | ZP5-9676 600 mg dose |
|
| Treatment B | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZP5-9676 600 mg dose | Drug | oral, chewable tablet formulation of flubendazole |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cure rates | Cure rates (CRs) for each STH | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Egg reduction | Egg reduction rates (ERRs) for hookworm | 14 days |
| Cure rates | Cure rates of hookworm | 14 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helen Pentikis | Contact | 4103364031 | hpentikis@zeropointfivetherapeutics.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica de Vacinas | Recruiting | Americaninha | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
prospective, randomized, double-blind, placebo-controlled study
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Matching placebo |
|