Actively Recruiting
Phase Ib Randomized Study to Assess Safety, Tolerability, and Pharmacokinetics of Oral ZY19489-Ferroquine Combination in Adult Asymptomatic Plasmodium Falciparum Carriers
Led by Zydus Lifesciences Limited · Updated on 2024-10-01
36
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Malaria, caused by Plasmodium parasites, remains a leading cause of illness and death worldwide, with Plasmodium falciparum responsible for most fatalities, especially in young children. This study aims to evaluate a new combination therapy of ZY19489 and ferroquine (FQ) designed to treat asymptomatic adult carriers of P. falciparum with a shorter dosing regimen. The goal is to assess the safety and tolerability of this combination given as a one- or two-day oral treatment. Participants will be randomly assigned to receive the ZY19489-FQ combination or placebo orally after fasting for at least 10 hours. Three dosing cohorts will be tested: one with 600 mg each of ZY19489 and FQ once daily, another with 900 mg each once daily, and a third cohort receiving 600 mg each daily for two days. The study includes a total of 36 adults divided across the cohorts. Each participant will be involved in screening visits followed by approximately 64 days of follow-up, totaling around 10 weeks in the trial. Researchers will monitor safety by recording any adverse events and evaluate pharmacokinetics, including drug concentration and elimination measures from the time of dosing until study completion. Participants will undergo scheduled visits for assessments, laboratory tests, and adherence monitoring throughout the study period.
CONDITIONS
Brief Title
A Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combination ZY19489-Ferroquine in Adult Asymptomatic Plasmodium Falciparum Carriers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female (non-pregnant, non-lactating) subjects aged between 18 and 55 years old
- Body weight of at least 45 kg
- Evidence of asymptomatic Plasmodium falciparum infection with parasite density between 20/µL and 5000/µL
- Agreement not to donate blood during the study and follow-up period
- Ability to swallow oral medication
- Signed informed consent obtained prior to participation
- Willingness and ability to comply with scheduled visits, treatment plan, and study procedures
You will not qualify if you...
- Mixed Plasmodium infection
- Clinically significant infectious disease or fever (temperature ≥38°C or 100.4°F) within 14 days before enrollment
- History of alcohol or drug abuse or positive urine tests for alcohol or drugs
- Consumption of xanthine-containing beverages or food (e.g., chocolate, coffee) within 48 hours before enrollment
- Known allergy to study drugs or rescue medications including artemisinin derivatives and lumefantrine
- Receipt of certain antimalarial treatments within specified timeframes before screening (e.g., piperaquine within 6 weeks, chloroquine within 4 weeks, artemisinin derivatives within 14 days)
- Laboratory or clinical abnormalities judged clinically significant by the investigator
- Glomerular filtration rate below 60 ml/min
- Previous malaria vaccine study participation or malaria vaccination within 3 months
- Participation in other clinical studies within 90 days before screening
- Pregnant or nursing women
- Sexually active participants not willing to use effective contraception during the study
- Participants considered at particular risk by the investigator for receiving antimalarial treatment or study participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - 1 to 2 days
Participants receive oral doses of the ZY19489-Ferroquine combination or placebo once daily for one or two days following a fasting period of at least 10 hours.
1 to 2 dosing visits
Duration - 64 days
Participants are monitored for safety, tolerability, and pharmacokinetics up to 64 days after dosing.
Visits throughout follow-up period
Trial Site Locations
Total: 1 location
1
Centre de Recherches Médicales de Lambaréné
Lambaréné, Gabon
Actively Recruiting
Research Team
K
Kevinkumar Kansagra, MD
D
Dr Hardik Patel, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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