Pulmonary Disease, Chronic ObstructivePhase 1NCT05016687
First-in-human Clinical Trial Evaluating CUR-N399 in Healthy Volunteers.
A Phase 1 study testing CUR-N399 in people with Pulmonary Disease, Chronic Obstructive and Enterovirus Infections, run by Curovir AB at 1 site in Sweden.
Trial summary
The purpose of the trial is to evaluate CUR-N399, a PI4KB inhibitor, in a first-in-human trial to evaluate the safety, tolerability and pharmacokinetics profile of single and multiple ascending doses in healthy adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Enterovirus Infections, Rhinovirus
- What is being tested?
- CUR-N399
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSweden
- Study dates
- 22 Jul 2021to 22 Mar 2022
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent for participation in the study.
- Part I and IIa: Healthy male or female subject aged 18-50 years inclusive. Part IIb: Healthy male or female subject aged ≥65 years inclusive.
- Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
- WOCBP must practice abstinence (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD] or intrauterine hormone-releasing system [IUS]) from at least 4 weeks prior to dose to 4 weeks after last dose. Female subjects must refrain from donating eggs from the date of dosing until 3 months after dosing with the IMP. Their male partner must agree to use a condom during the same time frame if he has not undergone vasectomy.
- Women of non-childbearing potential are defined as pre-menopausal females who are sterilised (tubal ligation or permanent bilateral occlusion of fallopian tubes); or females who have undergone hysterectomy or bilateral oophorectomy; or post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle stimulating hormone [FSH] 25-140 IE/L is confirmatory).
- Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP. Their female partner of child-bearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see above). -
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Current or history of gastrointestinal bleedings, inflammatory bowel disease, irritable bowel syndrome or coeliac disease, as judged by the Investigator.
- Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the study.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and HIV.
Show all 20Show fewer
- After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges: Part I, IIa: Systolic blood pressure <90 or >140 mmHg, or Diastolic blood pressure <50 or >90 mmHg, or Pulse <40 or >90 beats per minute (bpm) Part IIb: Systolic blood pressure <90 or >160 mmHg, or Diastolic blood pressure <50 or >100 mmHg, or Pulse <40 or >90 bpm
- Prolonged QTcF (>450 ms for men, >470 ms for women), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to CUR-N399.
- Regular use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins and minerals within 2 weeks prior to the (first) administration of IMP, at the discretion of the Investigator. NB. The use of a stable dose of levothyroxine is allowed for subjects in Part IIb.
- Any use of omeprazole products (or products of the same drug class) within 2 weeks prior to the (first) administration of IMP, at the discretion of the Investigator.
- Planned treatment or treatment with another investigational drug within 3 months prior to Day -1. Subjects consented and screened but not dosed in previous Phase I studies are not excluded.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, chewing tobacco) less than three times per week is allowed before screening visit.
- Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to (first) administration of the IMP.
- History or presence of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- Presence or history of drug abuse, as judged by the Investigator.
- History of, or current use of, anabolic steroids.
- Excessive caffeine consumption defined by a daily intake of >5 cups of caffeine containing beverages.
- Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
- Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Single-centre, Placebo-controlled, First-in-human Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of CUR-N399 in Healthy Volunteers.
The purpose of the trial is to evaluate CUR-N399, a PI4KB inhibitor, in a first-in-human trial to evaluate the safety, tolerability and pharmacokinetics profile of single and multiple ascending doses in healthy adults.
In the SAD part of the trial, single oral doses of CUR-N399 will be administered in 5 sequential cohorts. In all cohorts, safety and PK will be assessed before and after dose. Exploratory nasopharyngeal swab for assessment of airway infectants will be performed before dose and in the morning of Day 3.
Read more
In SAD part Cohort 4: A urine sample will be taken from the first morning void on Day 1 and urine will be collected for potential quantification of CUR-N399 (and metabolites) during the first 24 hours post-dose.
The MAD part of the trial will explore multiple ascending dosing of CUR-N399. The initial dose, dose escalation and dosing schedule will be based on emerging knowledge of safety, tolerability and PK of CUR-N399 observed in the SAD part of the trial. CUR-N399 will be administered in 3 sequential cohorts. An additional MAD cohort will evaluate CUR-N399 in older adults ≥65 years.
All SAD and MAD cohorts will evaluate 8 subjects. Within each cohort, subjects will be randomised in a 3:1 ratio to receive CUR-N399 (n=6) or placebo (n=2) in a blinded fashion.
- Being tested
- CUR-N399, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Enterovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUR-N399Drug
CUR-N399 will be administered as oral capsules.
PlaceboDrug
Placebo capsules matching CUR-N399 will administered.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Part I Cohort 1-5: CUR-N399 | Experimental | Healthy subjects 18-55 years will receive single ascending doses of CUR-N399. Planned doses for respective Cohorts: Cohort 1: 2.5 mg, Cohort 2: 7.5 mg, Cohort 3: 17.5 mg, Cohort 4: 35 mg, Cohort 5: 50 mg. Receives: Drug: CUR-N399 |
| Experimental Part I Cohort 1-5: Placebo | Placebo comparator | Healthy subjects will receive Placebo to match treatment of CUR-N399. Receives: Drug: Placebo |
| Experimental Part IIa Cohort 1-3: CUR-N399 | Experimental | Healthy subjects 18-55 years will receive multiple ascending doses of CUR-N399 during a 7-day period. Planned doses for respective Cohorts: Cohort 1: 10 mg/day, Cohort 2: 25 mg/day, Cohort 3: 50 mg/day. Receives: Drug: CUR-N399 |
| Experimental Part IIa Cohort 1-3: Placebo | Placebo comparator | Healthy subjects 18-55 years will receive Placebo to match CUR-N399 treatment during a 7-day period. Receives: Drug: Placebo |
| Experimental Part IIb: CUR-N399 | Experimental | Healthy subjects >/= 65 years will receive multiple ascending doses of CUR-N399 during a 7-day period. The dose to be administered will determined based on safety results in Part IIa. Receives: Drug: CUR-N399 |
| Experimental Part IIb: Placebo | Placebo comparator | Healthy subjects >/= 65 years will receive Placebo to match CUR-N399 treatment during a 7-day period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Parts: Adverse events (AE)
- Incidence (frequency, intensity and seriousness) of AEs
Measured: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
All Parts: Clinically significant changes in electrocardiograms (ECGs)
- Single 12-lead ECG will be recorded in supine position after 10 minutes of rest using an ECG machine. HR and PR, QRS, QT and QTcF intervals will be recorded.
Measured: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
All Parts: Clinically significant changes in vital signs (pulse)
- Pulse will be recorded.
Measured: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
All Parts: Clinically significant changes in vital signs (blood pressure)
- Blood pressure will be recorded.
Measured: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
All Parts: Clinically significant changes in safety laboratory parameters (clinical chemistry)
- Blood samples for analysis of clinical chemistry parameters:
- Alanine aminotransferase (ALT)
- Albumin
- Alkaline phosphatase (ALP)
- Aspartate aminotransferase (AST)
- Bilirubin (total and conjugated)
- Calcium
- Cholesterol (HDL, LDL, total)
- Creatinine (estimated Glomerular Filtration Rate [eGFR] included)
- C-reactive protein (CRP)
- Glucose
- Lactate dehydrogenase (LD)
- Phosphate
- Potassium
- Sodium
- Triglycerides
- Urea will be collected and sent to the certified clinical chemistry laboratory and analysed by routine analytical methods.
Measured: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
All Parts: Clinically significant changes in safety laboratory parameters (heamatology)
- Blood samples for analysis of haematology parameters:
- Haematocrit
- Haemoglobin (Hb)
- Platelet count
- Red blood cell (RBC) count
- White blood cell (WBC) count with differential count will be collected and sent to the certified clinical chemistry laboratory and analysed by routine analytical methods.
Measured: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
All Parts: Clinically significant changes in safety laboratory parameters (coagulation)
- Blood samples for analysis of coagulation parameters:
- Activated Partial Thromboplastin Time (APTT)
- Prothrombin Complex International Normalised Ratio (PK[INR]) will be collected and sent to the certified clinical chemistry laboratory and analysed by routine analytical methods.
Measured: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
All Parts: Clinically significant changes in physical examinations
- Routine physical examinations will be performed. Incidence of clinically significant changes will be recorded.
Measured: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
Secondary outcomes (11)
All Parts: Pharmacokinetics (PK) of CUR-N399 (AUC0-t)
Area under the curve (AUC) from time 0 to time t (AUC0-t)
Measured: Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)
All Parts: Pharmacokinetics (PK) of CUR-N399 (AUC0-∞)
AUC from time 0 to infinity (AUC0-∞)
Measured: Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)
All Parts: Pharmacokinetics (PK) of CUR-N399 (T½)
Terminal half-life (T½)
Measured: Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)
All Parts: Pharmacokinetics (PK) of CUR-N399 (Cmax)
Observed maximum plasma concentration (Cmax)
Measured: Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)
All Parts: Pharmacokinetics (PK) of CUR-N399 (Tmax)
Time to Cmax (Tmax)
Measured: Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)
All Parts: Pharmacokinetics (PK) of CUR-N399 (dose proportionality)
Dose proportionality (based on AUC and Cmax)
Measured: Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)
All Parts: Pharmacokinetics (PK) of CUR-N399 (CL/F)
Apparent total body clearance following extravascular administration (CL/F)
Measured: Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)
All Parts: Pharmacokinetics (PK) of CUR-N399 (Vz/F)
Apparent volume of distribution following extravascular administration (Vz/F)
Measured: Pre-dose Day 1 to 48 post last dose (Day 3 SAD and Day 9 MAD respectively)
Part II a+b: Pharmacokinetics (PK) of CUR-N399 (AUCtau) for MAD groups
AUC for the dosing interval (AUCtau)
Measured: After first dose (Day 1) and up to 48 hours post last dose (Day 9)
Part II a+b: Pharmacokinetics (PK) of CUR-N399 (Ctrough) for MAD groups
Observed concentration at the end of a dosing interval (Ctrough)
Measured: Pre-dose administration on Days 2 to 7
Part II a+b: Pharmacokinetics (PK) of CUR-N399 (Accumulation ratio) for MAD groups
Accumulation ratio
Measured: Day 1 to 48 hours post last dose (Day 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start22 Jul 2021
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curovir AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
- Investigators
- Nina Lindblom, PhD, Study director, Curovir AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016687
- Sponsor's protocol ID
- CURCT-001
- Status last verified
- Mar 2022
- First submitted
- 2 Jul 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Single-centre, Placebo-controlled, First-in-human Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of CUR-N399 in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT05016687
- Acronym / sponsor ID
- CURCT-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Curovir ABIndustry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 23 Aug 2021 (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.
The purpose of the trial is to evaluate CUR-N399, a PI4KB inhibitor, in a first-in-human trial to evaluate the safety, tolerability and pharmacokinetics profile of single and multiple ascending doses in healthy adults.
In the SAD part of the trial, single oral doses of CUR-N399 will be administered in 5 sequential cohorts. In all cohorts, safety and PK will be assessed before and after dose. Exploratory nasopharyngeal swab for assessment of airway infectants will be performed before dose and in the morning of Day 3.
In SAD part Cohort 4: A urine sample will be taken from the first morning void on Day 1 and urine will be collected for potential quantification of CUR-N399 (and metabolites) during the first 24 hours post-dose.
The MAD part of the trial will explore multiple ascending dosing of CUR-N399. The initial dose, dose escalation and dosing schedule will be based on emerging knowledge of safety, tolerability and PK of CUR-N399 observed in the SAD part of the trial. CUR-N399 will be administered in 3 sequential cohorts. An additional MAD cohort will evaluate CUR-N399 in older adults ≥65 years.
All SAD and MAD cohorts will evaluate 8 subjects. Within each cohort, subjects will be randomised in a 3:1 ratio to receive CUR-N399 (n=6) or placebo (n=2) in a blinded fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experimental Part I Cohort 1-5: CUR-N399 | Experimental | Drug: CUR-N399Healthy subjects 18-55 years will receive single ascending doses of CUR-N399. Planned doses for respective Cohorts: Cohort 1: 2.5 mg, Cohort 2: 7.5 mg, Cohort 3: 17.5 mg, Cohort 4: 35 mg, Cohort 5: 50 mg. |
| Experimental Part I Cohort 1-5: Placebo | Placebo comparator | Drug: PlaceboHealthy subjects will receive Placebo to match treatment of CUR-N399. |
| Experimental Part IIa Cohort 1-3: CUR-N399 | Experimental | Drug: CUR-N399Healthy subjects 18-55 years will receive multiple ascending doses of CUR-N399 during a 7-day period. Planned doses for respective Cohorts: Cohort 1: 10 mg/day, Cohort 2: 25 mg/day, Cohort 3: 50 mg/day. |
| Experimental Part IIa Cohort 1-3: Placebo | Placebo comparator | Drug: PlaceboHealthy subjects 18-55 years will receive Placebo to match CUR-N399 treatment during a 7-day period. |
| Experimental Part IIb: CUR-N399 | Experimental | Drug: CUR-N399Healthy subjects >/= 65 years will receive multiple ascending doses of CUR-N399 during a 7-day period. The dose to be administered will determined based on safety results in Part IIa. |
| Experimental Part IIb: Placebo | Placebo comparator | Drug: PlaceboHealthy subjects >/= 65 years will receive Placebo to match CUR-N399 treatment during a 7-day period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to give written informed consent for participation in the study.
- Part I and IIa: Healthy male or female subject aged 18-50 years inclusive. Part IIb: Healthy male or female subject aged ≥65 years inclusive.
- Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
- WOCBP must practice abstinence (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD] or intrauterine hormone-releasing system [IUS]) from at least 4 weeks prior to dose to 4 weeks after last dose. Female subjects must refrain from donating eggs from the date of dosing until 3 months after dosing with the IMP. Their male partner must agree to use a condom during the same time frame if he has not undergone vasectomy.
Key exclusion criteria (20 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Current or history of gastrointestinal bleedings, inflammatory bowel disease, irritable bowel syndrome or coeliac disease, as judged by the Investigator.
- Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the study.
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 |
|---|---|---|
| CUR-N399CUR-N399 will be administered as oral capsules. | Drug | Experimental Part I Cohort 1-5: CUR-N399, Experimental Part IIa Cohort 1-3: CUR-N399, Experimental Part IIb: CUR-N399 |
| PlaceboPlacebo capsules matching CUR-N399 will administered. | Drug | Experimental Part I Cohort 1-5: Placebo, Experimental Part IIa Cohort 1-3: Placebo, Experimental Part IIb: Placebo |
Primary outcome
All Parts: Adverse events (AE)
Time frame: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
• Incidence (frequency, intensity and seriousness) of AEs
All Parts: Clinically significant changes in electrocardiograms (ECGs)
Time frame: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
• Single 12-lead ECG will be recorded in supine position after 10 minutes of rest using an ECG machine. HR and PR, QRS, QT and QTcF intervals will be recorded.
All Parts: Clinically significant changes in vital signs (pulse)
Time frame: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
• Pulse will be recorded.
All Parts: Clinically significant changes in vital signs (blood pressure)
Time frame: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
• Blood pressure will be recorded.
All Parts: Clinically significant changes in safety laboratory parameters (clinical chemistry)
Time frame: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
• Blood samples for analysis of clinical chemistry parameters: * Alanine aminotransferase (ALT) * Albumin * Alkaline phosphatase (ALP) * Aspartate aminotransferase (AST) * Bilirubin (total and conjugated) * Calcium * Cholesterol (HDL, LDL, total) * Creatinine (estimated Glomerular Filtration Rate [eGFR] included) * C-reactive protein (CRP) * Glucose * Lactate dehydrogenase (LD) * Phosphate * Potassium * Sodium * Triglycerides * Urea will be collected and sent to the certified clinical chemistry laboratory and analysed by routine analytical methods.
All Parts: Clinically significant changes in safety laboratory parameters (heamatology)
Time frame: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
• Blood samples for analysis of haematology parameters: * Haematocrit * Haemoglobin (Hb) * Platelet count * Red blood cell (RBC) count * White blood cell (WBC) count with differential count will be collected and sent to the certified clinical chemistry laboratory and analysed by routine analytical methods.
All Parts: Clinically significant changes in safety laboratory parameters (coagulation)
Time frame: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
• Blood samples for analysis of coagulation parameters: * Activated Partial Thromboplastin Time (APTT) * Prothrombin Complex International Normalised Ratio (PK[INR]) will be collected and sent to the certified clinical chemistry laboratory and analysed by routine analytical methods.
All Parts: Clinically significant changes in physical examinations
Time frame: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)
• Routine physical examinations will be performed. Incidence of clinically significant changes will be recorded.
11 secondary outcomes
All Parts: Pharmacokinetics (PK) of CUR-N399 (AUC0-t)
Time frame: Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)
All Parts: Pharmacokinetics (PK) of CUR-N399 (AUC0-∞)
Time frame: Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)
All Parts: Pharmacokinetics (PK) of CUR-N399 (T½)
Time frame: Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)
All Parts: Pharmacokinetics (PK) of CUR-N399 (Cmax)
Time frame: Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)
All Parts: Pharmacokinetics (PK) of CUR-N399 (Tmax)
Time frame: Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)
All Parts: Pharmacokinetics (PK) of CUR-N399 (dose proportionality)
Time frame: Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)
All Parts: Pharmacokinetics (PK) of CUR-N399 (CL/F)
Time frame: Pre-dose Day 1 to 48 hours post last dose (Day 3 SAD and Day 9 MAD respectively)
All Parts: Pharmacokinetics (PK) of CUR-N399 (Vz/F)
Time frame: Pre-dose Day 1 to 48 post last dose (Day 3 SAD and Day 9 MAD respectively)
Part II a+b: Pharmacokinetics (PK) of CUR-N399 (AUCtau) for MAD groups
Time frame: After first dose (Day 1) and up to 48 hours post last dose (Day 9)
Part II a+b: Pharmacokinetics (PK) of CUR-N399 (Ctrough) for MAD groups
Time frame: Pre-dose administration on Days 2 to 7
Part II a+b: Pharmacokinetics (PK) of CUR-N399 (Accumulation ratio) for MAD groups
Time frame: Day 1 to 48 hours post last dose (Day 9)
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 23 Mar 2022.
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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.
Nina Lindblom, PhD study director
Curovir AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CUR-N399 in people with Pulmonary Disease, Chronic Obstructive and Enterovirus Infections, run by Curovir AB at 1 site in Sweden.
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 7 inclusion and 20 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 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
All Parts: Adverse events (AE) (time frame: From start of treatment Day 1 to End of Study (Day 8 SAD and Day 14 MAD)). The study lists 8 primary outcomes in all. 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 23 Mar 2022.