NCT00323375 is a Phase 1 clinical trial of AQ-13 in Malaria, sponsored by Tulane University Health Sciences Center.

Who is sponsoring NCT00323375?

NCT00323375 is sponsored by Tulane University Health Sciences Center.

What drugs are being tested in NCT00323375?

Interventions in NCT00323375: AQ-13, Chloroquine (CQ) Treatment.

Is NCT00323375 still recruiting?

NCT00323375 is currently completed. Last updated 8 December 2020.

Last reviewed 2020-12-08 · How we verify

NCT00323375

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Studies of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine

Completed Phase 1 Last updated 8 December 2020

What this trial tests

Phase 1 trial testing AQ-13 in Malaria in 122 participants. Completed in 31 August 2005.

Timeline

1 August 1999

Primary endpoint
30 June 2005

31 August 2005

Quick facts

Lead sponsor	Tulane University Health Sciences Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	basic science
Enrollment	122
Start date	1 August 1999
Primary completion	30 June 2005
Estimated completion	31 August 2005
Sites	1 location across United States

Drugs / interventions tested

AQ-13 — full drug profile →
Chloroquine (CQ) Treatment — full drug profile →

Conditions studied

Malaria — all drugs for Malaria →

Sponsor

Tulane University Health Sciences Center

Who can join

Adults 21 to 45, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The global pipeline of new medicines for the control and elimination of malaria.
Anthony MP, Burrows JN, Duparc S, Moehrle JJ, et al · · 2012 · cited 100× · PMID 22958514 · DOI 10.1186/1475-2875-11-316
Randomized dose-ranging controlled trial of AQ-13, a candidate antimalarial, and chloroquine in healthy volunteers.
Mzayek F, Deng H, Mather FJ, Wasilevich EC, et al · · 2007 · cited 98× · PMID 17213921 · DOI 10.1371/journal.pctr.0020006

Verify or expand the search:

Other recruiting trials for Malaria

Currently open trials in the same condition.

NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
NCT07036159 — A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months · Phase 2 · recruiting
NCT06735209 — First-in-Human PfSPZ-LARC2 Vaccination/CHMI · Phase 1 · active not recruiting
NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
NCT06607003 — Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Cha · Phase 1 · recruiting

Other Tulane University Health Sciences Center trials

Trials by the same sponsor.

NCT01832480 — Trichomonas Vaginalis Repeat Infections Among HIV Negative Women · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00323375 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tulane University Health Sciences Center
Last refreshed: 8 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00323375.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing