Studies of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine
Summary
The purpose of this protocol is to perform Phase 1 (safety/toxicity and pharmacokinetic) Studies of an investigational aminoquinoline antimalarial (AQ-13) in human subjects. The compound to be studied (AQ-13) is being examined because it is active in vitro against Plasmodium falciparum malaria parasites resistant to chloroquine (CQ) and other antimalarials (multi-resistant P. falciparum), and because its safety was similar to that of CQ in preclinical studies performed by SRI International (IND 55,670). AQ-13 was also selected for study because it is active in vivo in two monkey models of human malaria: 1\] P. cynomolgi in the rhesus monkey (Macaca mulatta), a model of human infection with P. vivax, and 2\] CQ-resistant P. falciparum in the squirrel monkey, a model of human infection with CQ-resistant P. falciparum.
Timeline
- Start
- 1999-08-01
- Primary completion
- 2005-06-30
- Completion
- 2005-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AQ-13 | Small molecule | 10 mg | Oral |
| Subject | AQ-13 | Small molecule | 100 mg | Oral |
| Subject | AQ-13 | Small molecule | 300 mg | Oral |
| Subject | AQ-13 | Small molecule | 600 mg | Oral |
| Subject | AQ-13 | Small molecule | 1750 mg | Oral |
| Comparator | Chloroquine | Small molecule | 10 mg | Oral |
| Comparator | Chloroquine | Small molecule | 100 mg | Oral |
| Comparator | Chloroquine | Small molecule | 300 mg | Oral |
| Comparator | Chloroquine | Small molecule | 600 mg | Oral |
| Comparator | Chloroquine | Small molecule | 1500 mg | Oral |