Uncomplicated Plasmodium Falciparum MalariaPhase 2PLATINUMNCT07235020
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria
A Phase 2 study testing INE963 in people with Uncomplicated Plasmodium Falciparum Malaria, run by Novartis Pharmaceuticals at 6 sites in 6 countries.
Trial summary
This is Cohort A1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 in participants with uncomplicated Plasmodium falciparum malaria. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Uncomplicated Plasmodium Falciparum Malaria
- What is being tested?
- INE963
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 23 Jan 2024to 21 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥18 years of age at screening.
- Patients must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 5,000 to 150,000 asexual parasite count/μl of blood for P. falciparum
- Patients must weigh between 40 kg and 90 kg.
- Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.
Who cannot join
- Patients with signs and symptoms of severe/complicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening
- Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level < 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening
- Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B or C, hepatitis A or B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening:
- AST/ALT > 3 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
- AST/ALT > 1.5 and ≤ 2 x ULN and total bilirubin is > ULN
- Total bilirubin > 2 x ULN, regardless of the level of AST/ALT
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- Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.
- Pregnant or nursing (lactating) women, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of effective contraception, and sexually active patients not willing to practice effective contraception.
- History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:
- Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
- History of familial long QT syndrome or known family history of Torsades de Pointe.
- Resting heart rate (physical exam or 12 lead ECG) < 50 bpm
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: A Multi-part, Multi-center PLATform Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Anti-malarial Agents Administered as Monotherapy and/or Combination Therapy IN Participants With Uncomplicated Plasmodium Falciparum Malaria
This is Cohort A1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 in participants with uncomplicated Plasmodium falciparum malaria.
Read the detailed description
The Cohort A1 of this Platfom study (NCT05750628) is an open-label, randomized, multi-arm monotherapy part evaluating a single oral administration of an anti-malarial agent (INE963) at 3 parallel dose levels followed by optional adaptive sequential dose level(s).
- Being tested
- INE963
- Keywords
- single dose cure malaria, uncomplicated malaria, Plasmodium falciparum, platform study, PLATINUM
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INE963Drug
Administered via oral INE963
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1: INE963 Dose Level 1 | Experimental | Cohort A1: INE963 Dose Level 1 Receives: Drug: INE963 |
| Cohort A1: INE963 Dose Level 2 | Experimental | Cohort A1: INE963 Dose Level 2 Receives: Drug: INE963 |
| Cohort A1: INE963 Dose Level 3 | Experimental | Cohort A1: INE963 Dose Level 3 Receives: Drug: INE963 |
| Cohort A1: INE963 Dose Level 4 | Experimental | Cohort A1: INE963 Dose Level 4 Receives: Drug: INE963 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasite clearance time (PCT)
To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in participants with uncomplicated P. falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.
Measured: up to Day 7
Secondary outcomes (9)
PCR-corrected and uncorrected ACPR
To assess the 28-day cure rate of an anti malarial agent administered orally as monotherapy in participants with uncomplicated P. falciparum malaria.
Measured: Day 29
Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as monotherapy.
Measured: Day 22
Area under the concentration-time curve from time zero to infinity (AUCinf)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Measured: Day 22
Maximum observed concentration (Cmax)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Measured: Day 22
Time to reach maximum observed concentration (Tmax)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Measured: Day 22
Elimination half-life (T1/2)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Measured: Day 22
Total body clearance (CL/F)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Measured: Day 22
Apparent volume of distribution (V/F)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Measured: Day 22
Area under the concentration-time curve (AUC0-t)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Measured: Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start23 Jan 2024
- Primary completion30 Jan 2025
- Study completion21 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235020
- Sponsor's protocol ID
- CADPT13A12201_A1
- Acronym
- PLATINUM
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-part, Multi-center PLATform Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Anti-malarial Agents Administered as Monotherapy and/or Combination Therapy IN Participants With Uncomplicated Plasmodium Falciparum Malaria
- ClinicalTrials.gov ID
- NCT07235020
- Acronym / sponsor ID
- PLATINUM / CADPT13A12201_A1
- Keywords
- single dose cure malaria, uncomplicated malaria, Plasmodium falciparum, platform study, PLATINUM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is Cohort A1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 in participants with uncomplicated Plasmodium falciparum malaria.
Detailed description
The Cohort A1 of this Platfom study (NCT05750628) is an open-label, randomized, multi-arm monotherapy part evaluating a single oral administration of an anti-malarial agent (INE963) at 3 parallel dose levels followed by optional adaptive sequential dose level(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A1: INE963 Dose Level 1 | Experimental | Drug: INE963Cohort A1: INE963 Dose Level 1 |
| Cohort A1: INE963 Dose Level 2 | Experimental | Drug: INE963Cohort A1: INE963 Dose Level 2 |
| Cohort A1: INE963 Dose Level 3 | Experimental | Drug: INE963Cohort A1: INE963 Dose Level 3 |
| Cohort A1: INE963 Dose Level 4 | Experimental | Drug: INE963Cohort A1: INE963 Dose Level 4 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients ≥18 years of age at screening.
- Patients must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 5,000 to 150,000 asexual parasite count/μl of blood for P. falciparum
- Patients must weigh between 40 kg and 90 kg.
- Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.
Key exclusion criteria (13 listed)
- Patients with signs and symptoms of severe/complicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening
- Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level < 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening
- Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B or C, hepatitis A or B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening:
- Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.
- Pregnant or nursing (lactating) women, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of effective contraception, and sexually active patients not willing to practice effective contraception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INE963Administered via oral INE963 | Drug | Cohort A1: INE963 Dose Level 1, Cohort A1: INE963 Dose Level 2, Cohort A1: INE963 Dose Level 3, Cohort A1: INE963 Dose Level 4 |
Primary outcome
Parasite clearance time (PCT)
Time frame: up to Day 7
To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in participants with uncomplicated P. falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.
9 secondary outcomes
PCR-corrected and uncorrected ACPR
Time frame: Day 29
Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)
Time frame: Day 22
Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: Day 22
Maximum observed concentration (Cmax)
Time frame: Day 22
Time to reach maximum observed concentration (Tmax)
Time frame: Day 22
Elimination half-life (T1/2)
Time frame: Day 22
Total body clearance (CL/F)
Time frame: Day 22
Apparent volume of distribution (V/F)
Time frame: Day 22
Area under the concentration-time curve (AUC0-t)
Time frame: Day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INE963 in people with Uncomplicated Plasmodium Falciparum Malaria, run by Novartis Pharmaceuticals at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Burkina Faso, Côte d’Ivoire, Gabon, Ghana, Kenya and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parasite clearance time (PCT) (time frame: up to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.