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A Phase 1a/1b Study of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03998514
Recruitment Status : Suspended (COVID-19 related delay)
First Posted : June 26, 2019
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
CohBar, Inc.

Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date June 19, 2020
Actual Study Start Date  ICMJE July 9, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • Incidence and severity of AEs [ Time Frame: up to 8 weeks for Part A; up to 9 weeks for Part B; up to 12 weeks for Part C ]
    Number of participants with treatment-related adverse events and serious adverse events
  • Clinical laboratory evaluations [ Time Frame: 7 days for Part A; 2 weeks for Part B; 5 weeks for Part C ]
    Number of participants with clinically significant abnormalities in clinical laboratory values
  • Vital Signs [ Time Frame: 7 days for Part A; 2 weeks for Part B; 5 weeks for Part C ]
    Number of participants with clinically significant abnormalities in vital signs
  • 12-lead ECG parameters [ Time Frame: 7 days for Part A; 2 weeks for Part B; 5 weeks for Part C ]
    Number of participants with clinically significant abnormalities in 12-lead ECGs
  • Physical examinations [ Time Frame: Time Frame: up to 8 weeks for Part A; up to 9 weeks for Part B; up to 12 weeks for Part C ]
    Number of participants with clinically significant abnormalities in physical examinations
  • Injection-site assessments [ Time Frame: up to 8 weeks for Part A; up to 9 weeks for Part B; up to 12 weeks for Part C ]
    Number of participants with treatment-related injection site reactions
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • Area under the blood/plasma concentration time curve from time zero to infinity of CB4211 [ Time Frame: 24 hours for Part A, 7 days for Part B, 28 days for Part C ]
    Area under the blood/plasma concentration time curve from time zero to infinity (AUC0-inf)
  • Area under the blood/plasma concentration time curve from time zero to the time of the last quantifiable concentration of CB4211 [ Time Frame: 24 hours for Part A, 7 days for Part B, 28 days for Part C ]
    Area under the blood/plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC0-t)
  • Area under the blood/plasma concentration time curve from time zero to 24 hours postdose of CB4211 [ Time Frame: 24 hours for Part A, 7 days for Part B, 28 days for Part C ]
    Area under the blood/plasma concentration time curve from time zero to 24 hours postdose (AUC0-24)
  • Maximum observed blood/plasma concentration of CB4211 [ Time Frame: 24 hours for Part A, 7 days for Part B, 28 days for Part C ]
    Maximum observed blood/plasma concentration (Cmax)
  • Time of the maximum observed blood/plasma concentration of CB4211 [ Time Frame: 24 hours for Part A, 7 days for Part B, 28 days for Part C ]
    Time of the maximum observed blood/plasma concentration (Tmax)
  • Apparent blood/plasma terminal elimination half life of CB4211 [ Time Frame: 24 hours for Part A, 7 days for Part B, 28 days for Part C ]
    Apparent blood/plasma terminal elimination half life (t1/2)
  • Apparent total blood/plasma clearance of CB4211 [ Time Frame: 24 hours for Part A, 7 days for Part B, 28 days for Part C ]
    Apparent total blood/plasma clearance (CL/F)
  • Apparent volume of distribution of CB4211 [ Time Frame: 24 hours for Part A, 7 days for Part B, 28 days for Part C ]
    Apparent volume of distribution(Vz/F)
  • Amount of CB4211 excreted in urine over the sampling interval [ Time Frame: 24 hours for Part A, 7 days for Part B, 28 days for Part C ]
    Amount of CB4211 excreted in urine over the sampling interval (Aeu)
  • Percentage of CB4211 excreted in urine [ Time Frame: 24 hours for Part A, 7 days for Part B, 28 days for Part C ]
    Percentage of CB4211 excreted in urine (%fe)
  • Renal clearance of CB4211 [ Time Frame: 24 hours for Part A, 7 days for Part B, 28 days for Part C ]
    Renal clearance (CLr)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 25, 2019)
  • Change from baseline in body weight [ Time Frame: 28 days for Part C only ]
    Change from baseline in body weight
  • Change from baseline in liver fat (as determined by magnetic resonance imaging-derived proton density fat fraction [MRI-PDFF]) [ Time Frame: 28 days for Part C only ]
    Change from baseline in liver fat (as determined by magnetic resonance imaging-derived proton density fat fraction [MRI-PDFF])
  • Proportion of subjects achieving various levels of liver fat reduction at end of treatment [ Time Frame: 28 days for Part C ]
    Proportion of subjects achieving various levels of liver fat reduction at end of treatment
  • Exploratory biomarkers [ Time Frame: Samples pre dose and post dose at 4, 8, 12, and 24 hours for Part A, at 7 days for Part B, and at 7, 14, 21 and 28 days for Part C ]
    For Parts A, B, and C, exploratory biomarker endpoints include glucose, insulin, triglycerides, NEFA, ALT, adiponectin, and other biomarkers may also be measured in an exploratory fashion. Changes from baseline at 24 hours (Part A), Day 7 (Part B) and Days 7, 14, 21, and 28 (Part C) will be assessed in glucose, insulin; triglycerides, NEFA, ALT, adiponectin, and other biomarkers as required.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase 1a/1b Study of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease
Official Title  ICMJE A Phase 1a/1b Study of Safety, Tolerability, and Pharmacokinetics of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease
Brief Summary This is a 3 part, randomized, double blind, placebo controlled study evaluating the safety, tolerability, PK, and PD of single and multiple ascending SC doses of CB4211 in healthy non obese subjects and subjects with NAFLD.
Detailed Description

Part A: Part A is a randomized, double blind, placebo controlled, single ascending dose sequential group study evaluating the safety, tolerability, PK, and PD of a single SC dose of CB4211 in healthy non obese subjects.

Part B: Part B is a randomized, double blind, placebo controlled, multiple ascending dose sequential group study evaluating the safety, tolerability, PK, and PD of once daily SC doses of CB4211 over 7 days in healthy non obese subjects.

Part C: Part C is a randomized, double blind, placebo controlled, multiple dose, parallel group study evaluating the safety, tolerability, PK, and PD of once daily SC doses of CB4211 over 28 days in subjects with NAFLD.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a 3-part, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, PK, and PD of single- and multiple-ascending SC doses of CB4211 in healthy subjects and subjects with NAFLD. Study treatment (CB4211 or placebo) will be administered SC into the abdomen (and if needed, upper and lower thigh) as bolus injections.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
randomized, double blind, placebo controlled
Primary Purpose: Treatment
Condition  ICMJE Nonalcoholic Fatty Liver Disease
Intervention  ICMJE
  • Drug: CB4211 Dose 1
    Administered by subcutaneous injection
  • Drug: CB4211 Dose 2
    Administered by subcutaneous injection
  • Drug: CB4211 Dose 3
    Administered by subcutaneous injection
  • Drug: CB4211 Dose 4
    Administered by subcutaneous injection
  • Drug: CB4211 Dose 5
    Administered by subcutaneous injection
  • Drug: CB4211 Dose 6
    Administered by subcutaneous injection
  • Drug: CB4211 Dose TBD
    Administered by subcutaneous injection
  • Drug: Placebo
    Administered by subcutaneous injection
Study Arms  ICMJE
  • Experimental: Group A1 SAD
    CB4211 Dose 1 (N=6) Placebo (N=2) Subcutaneous injection
    Interventions:
    • Drug: CB4211 Dose 1
    • Drug: Placebo
  • Experimental: Group A2 SAD
    CB4211 Dose 2 (N=6) Placebo (N=2) Subcutaneous injection
    Interventions:
    • Drug: CB4211 Dose 2
    • Drug: Placebo
  • Experimental: Group A3 SAD
    CB4211 Dose 3 (N=6) Placebo (N=2) Subcutaneous injection
    Interventions:
    • Drug: CB4211 Dose 3
    • Drug: Placebo
  • Experimental: Group A4 SAD
    CB4211 Dose 4 (N=1) Placebo (N=1) Subcutaneous injection
    Interventions:
    • Drug: CB4211 Dose 4
    • Drug: Placebo
  • Experimental: Group A5 SAD
    CB4211 Dose 5 (N=6) Placebo (N=2) Subcutaneous injection
    Interventions:
    • Drug: CB4211 Dose 5
    • Drug: Placebo
  • Experimental: Group A6 SAD
    CB4211 Dose 6 (N=6) Placebo (N=2) Subcutaneous injection
    Interventions:
    • Drug: CB4211 Dose 6
    • Drug: Placebo
  • Experimental: Group B1 MAD
    CB4211 Dose TBD (N=6) Placebo (N=2) Subcutaneous injection once daily for 7 days
    Interventions:
    • Drug: CB4211 Dose TBD
    • Drug: Placebo
  • Experimental: Group B2 MAD
    CB4211 Dose TBD (N=6) Placebo (N=2) Subcutaneous injection once daily for 7 days
    Interventions:
    • Drug: CB4211 Dose TBD
    • Drug: Placebo
  • Experimental: Group B3 MAD
    CB4211 Dose TBD (N=6) Placebo (N=2) Subcutaneous injection once daily for 7 days
    Interventions:
    • Drug: CB4211 Dose TBD
    • Drug: Placebo
  • Experimental: Part C
    CB4211 Dose TBD (N=10) Placebo (N=10) Subcutaneous injection once daily for 28 days
    Interventions:
    • Drug: CB4211 Dose TBD
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: June 25, 2019)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Parts A and B Inclusion Criteria:

  1. Males or females of nonchildbearing potential, of any race, 18 to 60 years of age, inclusive, at Screening.

    Females of nonchildbearing potential are defined as permanently sterile (ie, due to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) confirmed by history or postmenopausal (defined as at least 12 continuous months without menses and follicle-stimulating hormone [FSH] ≥40 mIU/L and without an alternative medical cause).

  2. Body mass index between 18.0 and 30.0 kg/m2 , inclusive, with a minimum body weight of 50.0 kg at Screening.
  3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is not acceptable) at Screening or Check-in as assessed by the Investigator (or designee).
  4. Male subjects who are surgically sterile for at least 90 days will not need to use contraception. Male subjects who are not surgically sterile for at least 90 days will be required to use a male condom with spermicide when sexually active with female partners of childbearing potential from Check-in until 90 days after the last dose of study drug. Sexual intercourse with female partners who are pregnant or breastfeeding should be avoided unless condoms are used from the time of the first dose until 90 days after the last dose of study drug. Male subjects are required to refrain from donation of sperm from Check-in until 90 days after the last dose of study drug.
  5. Has maintained stable weight (by history) for at least 4 weeks prior to Screening.
  6. Agrees to the following:

    • Not to initiate a weight-loss program from Screening until the Follow-up visit;
    • To refrain from strenuous exercise from 7 days before Check-in until the Follow-up visit;
    • To maintain consistent dietary habits and exercise routines for the duration of the study.
  7. Must have transaminases (AST and ALT) and total bilirubin within the normal range at Screening and Check-in. For other laboratory evaluations, the subject may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant.
  8. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Parts A and B Exclusion Criteria:

  1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
  2. Clinically significant ECG abnormalities or QTcF >450 milliseconds for males and >470 milliseconds for females at either Screening or Check-in, or any prior history of QT abnormality.
  3. Creatinine clearance of <90 mL/min at Screening, determined using the Cockcroft-Gault (C-G) equation.
  4. History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
  5. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
  6. History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.
  7. Alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
  8. Positive urine drug screen (confirmed by repeat) at Screening or positive alcohol breath or urine test result or positive urine drug screen at Check-in.
  9. Positive hepatitis panel and/or positive human immunodeficiency virus test. Subjects with serologic finding of immunity consistent with history of prior hepatitis B vaccination may be enrolled.
  10. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing or have received a biological product within 3 months or 5 elimination half-lives (whichever is longer) prior to dosing.
  11. Use of prescription drugs, nonprescription drugs, dietary supplements including Vitamin E, herbal supplements, hormonal therapy/replacement, or CYP3A4 substrates, inducers and inhibitors within 14 days prior to the first dose of study drug unless, in the opinion of the Investigator and Sponsor's Medical Monitor, the medication will not interfere with the study procedures or compromise subject safety.
  12. Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
  13. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 14 days prior to the first dose of study medication, unless deemed acceptable by the Investigator (or designee).
  14. Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.
  15. Receipt of blood products within 2 months prior to Check-in.
  16. Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
  17. Poor peripheral venous access.
  18. Have previously completed or withdrawn from this study or any other study investigating CB4211, and have previously received the investigational product.
  19. Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.

Part C Inclusion Criteria:

  1. Males or females of nonchildbearing potential, of any race, 18 to 60 years of age, inclusive, at Screening.

    Females of nonchildbearing potential are defined as permanently sterile (ie, due to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) confirmed by history or postmenopausal (defined as at least 12 continuous months without menses and FSH ≥40 mIU/L and without an alternative medical cause).

  2. Body mass index ≥30.0 kg/m2, and body weight ≤115 kg at Screening.
  3. History of Fatty Liver Index (FLI) score >60 or documented history of fatty liver with imaging results (eg, standard positive ultrasound or Fibroscan CAP >300 dB/m) indicating liver fat >10% within 6 months of Screening. A formal diagnosis of NAFLD is not required.
  4. Fibroscan CAP >300 dB/m within 6 weeks prior to Check-in.
  5. Liver fat content ≥10% as determined by MRI-PDFF within 10 days prior to Check in.
  6. No history of common causes of secondary hepatic steatosis such as:

    1. Macrovesicular steatosis: excessive alcohol consumption, hepatitis C (genotype 3), Wilson's disease, lipodystrophy, starvation, parenteral nutrition, abetalipoproteinemia, medications (eg, amiodarone, methotrexate, tamoxifen, corticosteroids, or any drug known to affect hepatic steatosis or insulin resistance)
    2. Microvesicular steatosis: Reye's syndrome, medications (valproate, anti-retroviral medicines), acute fatty liver of pregnancy, HELLP syndrome, inborn errors of metabolism (eg, lecithin-cholesterol acyltransferase deficiency, cholesterol ester storage disease, Wolman disease, lysosomal acid lipase deficiency)
  7. Glycosylated hemoglobin A1c of ≥4.0% to ≤6.4% at Screening.
  8. Fasting blood glucose of ≥100 to <126 mg/dL at Screening.
  9. Serum triglyceride level ≤500 mg/dL at Screening
  10. Have INR <ULN and platelet count >150,000 at Screening and Check-in. For other abnormalities, the subject may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant.
  11. In subjects with ALT, AST, ALP, or total bilirubin > ULN at Screening, the baseline measurement (BLM) should be determined by 2 separate measurements obtained approximately 4 weeks apart. To be eligible for study entry, the Screening ALT, AST, ALP, and total bilirubin must be < ULN or the following criteria must be met prior to randomization:

    1. ALT ≤3 x ULN for both measurements and the difference between the measurements should be <20% of the lower value;
    2. AST ≤3 x ULN for both measurements and the difference between the measurements should be <20% of the lowest value;
    3. ALP ≤3 x ULN for both measurements and the difference between the measurements should be <20% of the lowest value;
    4. Total bilirubin <ULN for both measurements and the difference between themeasurements should be <20% of the lowest value.
  12. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is not acceptable) at Screening or Check-in as assessed by the Investigator (or designee).
  13. Male subjects who are surgically sterile for at least 90 days will not need to use contraception. Male subjects who are not surgically sterile for at least 90 days will be required to use a male condom with spermicide when sexually active with female partners of childbearing potential from Check-in until 90 days after the last dose of study drug. Sexual intercourse with female partners who are pregnant or breastfeeding should be avoided unless condoms are used from the time of the first dose until 90 days after the last dose of study drug. Male subjects are required to refrain from donation of sperm from Check-in until 90 days after the last dose of study drug.
  14. Has maintained stable weight (by history) for at least 4 weeks prior to Screening.
  15. Agrees to the following:

    • Not to initiate a weight-loss program from Screening until the Follow-up visit;
    • To refrain from strenuous exercise from 7 days before Check-in until the Follow-up visit;
    • To maintain consistent dietary habits and exercise routines for the duration of the study.
  16. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Part C Exclusion Criteria:

  1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic (except for NAFLD), renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
  2. Clinically significant ECG abnormalities or QTcF >450 milliseconds for males and 470 milliseconds for females at either Screening or Check-in, or any prior history of QT abnormality.
  3. Currently using any antidiabetic medication (eg, metformin, insulin, glucagon-like peptide-1 analogs, agonist therapy).
  4. Use of fibrates or statins within 6 weeks prior to Check-in.
  5. Use of Vitamin E, agents associated with changes in liver fat, or agents used for treatment of NAFLD or NASH within 3 months prior to Screening.
  6. Change in body weight >5% within the 3 months prior to Check-in.
  7. History of bariatric surgery and any other gastrointestinal surgery relative to weight loss (eg, Roux-en-Y gastric bypass, laparoscopic adjustable gastric banding, sleeve gastrectomy, duodenal switch with biliopancreatic diversion).
  8. Claustrophobia or other contraindication to magnetic resonance imaging.
  9. Creatinine clearance of <90 mL/min at Screening, determined using the C-G equation.
  10. History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
  11. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
  12. History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.
  13. Alcohol consumption of >14 units per week for males and >7 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
  14. Positive urine drug screen (confirmed by repeat) at Screening or positive alcohol breath or urine test result or positive urine drug screen at Check-in.
  15. Positive hepatitis panel and/or positive human immunodeficiency virus test. Subjects with serologic finding of immunity consistent with history of prior hepatitis B vaccination may be enrolled.
  16. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing or have received a biological product within 3 months or 5 elimination half-lives (whichever is longer) prior to dosing.
  17. Use of prescription drugs, nonprescription drugs, dietary supplements including peroxisome proliferator-activated receptor-γ agonists, drugs known to affect insulin sensitivity, herbal supplements, hormonal therapy/replacement, or CYP3A4 substrates, inducers, and inhibitors within 14 days or 5 elimination half-lives (whichever is longer) prior to the first dose of study drug unless, in the opinion of the Investigator and Sponsor's Medical Monitor, the medication will not interfere with the study procedures or compromise subject safety.
  18. Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
  19. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 14 days prior to the first dose of study medication, unless deemed acceptable by the Investigator (or designee).
  20. Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.
  21. Receipt of blood products within 2 months prior to Check-in.
  22. Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
  23. Poor peripheral venous access.
  24. Have previously completed or withdrawn from this study or any other study investigating CB4211, and have previously received the investigational product.
  25. Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03998514
Other Study ID Numbers  ICMJE CB-4211-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CohBar, Inc.
Study Sponsor  ICMJE CohBar, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CohBar, Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP