Phase 2
N=22
Efficacy of SJ733 in Adults With Uncomplicated Plasmodium Falciparum or Vivax Malaria
Malaria, Falciparum · Malaria, Vivax
Bottom Line
View on ClinicalTrials.gov: NCT04709692 ↗Enrolled (actual)
22
Serious AEs
9.1%
Results posted
Dec 2023
Primary outcome: Primary: Crude Adequate Clinical and Parasitological Response (ACPR) — 90; 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- (+)-SJ000557733 (SJ733) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- R. Kiplin Guy
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crude Adequate Clinical and Parasitological Response (ACPR) |
90; 100 | — |
| PRIMARY Percent of Patients With Treatment Related Adverse Events |
0; 0 | — |
| PRIMARY Percent of Patients With Clinically Significant Abnormal Laboratory Values |
0; 2 | — |
| PRIMARY Percent of Patients With Clinically Significant Abnormal Vital Signs |
0; 0 | — |
| PRIMARY Percent of Patients With a Decrease in Hemoglobin (HB) > 2 g/dL From Baseline to an Absolute Value of < 5 g/dL |
0; 0 | — |
| PRIMARY Percent of Patients With an Absolute Neutrophil Count < 1,000/μL After Baseline |
1; 0 | — |
| PRIMARY Percent of Patients Meeting Hy's Law Criteria |
0; 0 | — |
| PRIMARY Percent of Patients With Any ALT or AST ≥ 5 x ULN |
0; 0 | — |
| PRIMARY Percent of Patients With a ny AST or ALT ≥ 3 x ULN Together With the Appearance of Fatigue, Nausea, Vomiting, Right Upper Quadrant Pain or Tenderness, Fever, Rash and/or Eosinophilia |
0; 0 | — |
| PRIMARY Percent of Patients With Persistent ALT ≥ 3 x ULN for a Period of More Than 4 Weeks. |
0; 0 | — |
| PRIMARY Percent of Patients With Clinical Signs of Possible Cutaneous Adverse Reactions |
0; 0 | — |
| PRIMARY Percent of Patients With Clinically Significant Increases in Venous Methemoglobin Levels |
0; 0 | — |
| PRIMARY Percent of Patients With Significant Changes in ECG Findings |
0; 0 | — |
| SECONDARY Number of Participants With Signs and Symptoms of Uncomplicated Malaria |
10; 12 | — |
| SECONDARY Parasite Clearance Time |
15.60; 45.78 | — |
| SECONDARY Parasite Reduction Rate |
-0.33; -0.08 | — |
| SECONDARY Asexual Parasite Clearance Time |
15.60; 45.78 | — |
| SECONDARY Percent Change in Asexual Parasites From Baseline |
-100; -97; -100; -99.5; -100; -99.8 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve (AUC) |
110325; 24688.1; 14123.7; 31793.6; 271632.1; 56991.9 | — |
| SECONDARY Maximum Plasma Drug Concentration (Cmax) |
9207.6; 2730.3; 1244; 2918.2 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) |
53.97; 49.03 | — |
| SECONDARY Drug Clearance |
4.51; 16.06; 19.49; 12.95 | — |
| SECONDARY Crude Adequate Clinical and Parasitological Response (ACPR) at Days 28, 35, and 42 |
20; 30; 20; 20; 20; 10 | — |
| SECONDARY Time to Recurrence of Malaria Infection |
25.0; 24.1 | — |
| SECONDARY Fever Clearance Time |
9.200; 6.667 | — |
Summary
This Phase 2a trial recruits adult patients with uncomplicated P. vivax or P. falciparum blood-stage malaria mono-infection. The study drug SJ733 will be administered to examine its antimalarial efficacy, safety, and tolerability. This study also evaluates whether or not a fixed dose of the pharmacoenhancer cobicistat when given in combination with SJ733 significantly improves drug efficacy.
Eligibility Criteria
Inclusion Criteria
- Male or female, aged 18 to 70 years of age (inclusive) at screening.
- Body weight between 45 kg and 90 kg inclusive
- Presence of mono-infection of P. falciparum or P. vivax confirmed by:
- Fever, as defined by axillary temperature ≥ 37.5°C or oral/rectal/tympanic temperature ≥ 38°C, or history of fever in the previous 24 hours (history of fever must be documented) and,
- Microscopically confirmed parasite infection: 1,000 to 40,000 asexual parasite count/µL blood
- Written informed consent provided by participant, in accordance with local practice. If the participant is unable to write, witnessed consent is permitted according to local ethical considerations.
- Ability to swallow oral medication.
- Ability and willingness to participate and to comply with the study requirements
- Agreement to hospitalization for at least 102 hours and/or until malarial parasites are not detected by microscopy on 2 consecutive occasions.
- Agreement to come back to the hospital on Days 7, 10 or 11, 14, 17 or 18, 21, 24 or 25, 28, 35, and 42.
- Women of child-bearing potential, has a negative pregnancy test at screening, and agrees to comply with one of the following during the treatment stage of the study and for a period of 90 days after stopping study drug:
- Use of oral, implantable, or injectable hormonal contraceptive, either combined or progestogen alone used in conjunction with barrier method as defined below.
- Use of an intrauterine device with a documented failure rate of 3 x upper limit of normal range (ULN) and total bilirubin is normal
- AST/ALT > 2 x ULN and total bilirubin is >1 and 35% of the total bilirubin
- Total bilirubin > 1.5 x ULN
- Serum creatinine levels > 2 x ULN
- Hb level < 8 g/dL
- Platelet level < 50,000/mm3
- Participation in a clinical study of another investigational small molecule within 30 days or investigational biologic within 90 days prior to study enrollment or planning to begin such participation during the study.
- Have received any antimalarial treatment (alone or in combination) in the past containing:
- Piperaquine, mefloquine, naphthoquine or sulphadoxine / pyrimethamine within the previous 6 weeks
- Amodiaquine or chloroquine within the previous 4 weeks
- Any artemisinin (artesunate, artemether, arteether or dihydroartemisinin) quinine, halofantrine, lumefantrine and any other anti-malarial treatment or antibiotics with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the past 14 days
- Any medication from the list of prohibited medications.
Data sourced from ClinicalTrials.gov (NCT04709692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.