Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00323375 · ClinicalTrials.gov registry record · Phase 1
Studies of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine
A Phase 1 study, sponsored by Tulane University Health Sciences Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 122
- Enrollment target
NCT00323375: Completed Phase 1 study, sponsored by Tulane University Health Sciences Center.
NCT00323375 is a Phase 1 study that has completed, run by Tulane University Health Sciences Center. The registered enrollment target is 122 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (103% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00323375, a Phase 1 study, has completed, sponsored by Tulane University Health Sciences Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 122 participants
- Enrollment target
Study 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.
Primary Outcome
AEs were recorded in diaries provided to study participants and were used for the 4 week period after dosing with AQ-13 or CQ. Based on those diaries, AEs were graded as mild or serious and from 1 to 4 based on the criteria developed by the Division of AIDS at NIAID (https://rsc.tech-res.com/docs/default-source/safety/daids-ae-grading-table-mar2017.pdf).
Interventions
- DRUG AQ-13
- DRUG Chloroquine (CQ) Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 1999-08-01 |
| Est. Completion | 2005-08-31 |
| Phase | Phase 1 |
What the finished NCT00323375 record still lists
NCT00323375 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (103% higher).
The record links to 0 conditions, and to 2 interventions - of which AQ-13 is the first listed.
NCT00323375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00323375 about?
NCT00323375 is a clinical study titled "Studies of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine". 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 paras...
What is the current status of trial NCT00323375?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 122 participants. The study started on 1999-08-01. Estimated completion is 2005-08-31.
What interventions are being tested in trial NCT00323375?
The interventions under investigation include: AQ-13 (DRUG), Chloroquine (CQ) Treatment (DRUG).
Who is sponsoring clinical trial NCT00323375?
This trial is sponsored by Tulane University Health Sciences Center, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00323375's enrollment target sits among peer trials
122 475th of 2000 higher than 1,525 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03363373 · 122 participants · Phase 2
Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
- NCT03463954 · 122 participants · NA
Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors
- NCT04503265 · 122 participants · Phase 1
A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
- NCT04700527 · 122 participants · Phase 1
The Effects of SCFA Supplementation in Subjects Receiving Abdominopelvic RT: A Randomized Controlled Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI