Testing a new oral treatment for asymptomatic malaria carriers

Phase Ib, Single-center, Randomized, Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combination ZY19489-Ferroquine in Adult Asymptomatic Plasmodium Falciparum Carriers

This study is testing a new oral treatment for adults who carry malaria without symptoms to see if it can provide a quick and effective cure.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Zydus Lifesciences Limited (industry)
• Locations: 1 site (Lambaréné)
• Trial ID: NCT05911828 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety, tolerability, and pharmacokinetics of a new combination therapy, ZY19489-Ferroquine, in adult participants who are asymptomatic carriers of Plasmodium falciparum. The study will involve 36 participants divided into three cohorts, each receiving the treatment orally for one or two days after a fasting period. The goal is to develop a simplified treatment regimen that could potentially provide a single-day cure for uncomplicated malaria, thereby improving treatment adherence and reducing transmission. Participants will be monitored for approximately 10 weeks, including screening and follow-up visits.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 who are asymptomatic carriers of Plasmodium falciparum with specific parasite density.

Not a fit: Patients with mixed Plasmodium infections or those who are pregnant or lactating will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and simpler regimen for managing asymptomatic malaria, potentially reducing morbidity and mortality.

How similar studies have performed: While the approach of developing a simplified treatment regimen is promising, the specific combination therapy being tested is novel and has not been extensively studied in this context.

Eligibility criteria

Inclusion Criteria:

\- 1. Male and female (non-pregnant, non-lactating) subjects aged between 18 and 55 years old 2. Participant's body weight ≥ 45 kg 3. Evidence of asymptomatic infection with Plasmodium falciparum mono-infection on microscopy with parasite density between 20/µL and 5000/µL.

4\. Participants should agree to not donate blood from enrolment in the study until end of the follow-up period 5. Ability to swallow oral medication 6. Evidence of written informed consent personally signed and dated by the participant.

Signed informed consent obtained prior to participation in the study. In case of participant unable to read and write or otherwise incapable of signing an informed consent, an impartial witnessed consent shall be obtained. Participants who are willing to and are able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* 1\. Mixed Plasmodium infection as judged by microscopy. 2. Presence of clinically significant infectious disease or fever (e.g. Body temperature ≥38°C or 100.4°F) within the 14 days prior to enrollment.

  3\. History of alcohol or drug abuse or positive urine alcohol test or urine drug test.

  4\. Consumption of beverages or food containing xanthine bases including chocolate, coffee etc. from 48 hours prior to enrollment.

  5\. Known allergy to the study drugs and to the rescue medications (artemisinin derivatives, lumefantrine) as well as their excipients.

  6\. History of having received any antimalarial treatment (alone or in combination) during the following periods before screening:
  1. Piperaquine, mefloquine, naphthoquine or sulfadoxine-pyrimethamine within 6 weeks prior to screening.
  2. Amodiaquine, chloroquine within 4 weeks prior to screening.
  3. Any artemisinin derivative (artesunate, artemether or dihydroartemisinin), quinine, lumefantrine or any other anti-malarial treatment or antibiotic with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones and azithromycin) within 14 days prior to screening.

     7\. Laboratory parameters outside normal range or with clinically relevant abnormalities as per investigator's judgment.

     8\. Electrolyte levels outside normal range 9. Hematology, clinical chemistry or urinalysis results at screening that were outside of clinically acceptable laboratory ranges and were considered clinically significant by the Investigator.

     10\. GFR\<60 ml/min. 11. Previous participation in any malaria vaccine study or received malaria vaccine in any other circumstance within 3 months of screening.

     12\. Participation in other clinical studies within 90 days before screening. 13. Pregnant or nursing (lactating) women. 14. Sexually active participants not willing to take effective contraception measures from enrolment until the last study visit: For female participants, combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner.

     15\. All male participants not willing to use either true abstinence, barrier method or with their sexual partner, the use of effective means of contraception from enrolment and until the last study visit.

     16\. Participant who the investigator considers at particular risk of receiving an anti-malarial or of participating in the study.

Where this trial is running

Lambaréné

• Centre de Recherches Médicales de Lambaréné — Lambaréné, Gabon (RECRUITING)

Study contacts

• Study coordinator: Kevinkumar Kansagra, MD

Conditions: Uncomplicated Malaria, Asymptomatic Condition, Falciparum Malaria