A Phase 3 interventional study of Ranquilon and Placebo in Anxiety, Neurasthenia and Adjustment Disorders, sponsored by Valenta Pharm JSC. Completed at 10 sites in Russian Federation. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Valenta Pharm JSC · Phase 3, Interventional, and Treatment
The primary objective of the study is to evaluate the efficacy of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo for the treatment of patients with anxiety in neurasthenia and adjustment disorder.
An additional study objective was to evaluate the safety of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo in patients with anxiety in neurasthenia and adjustment disorder.
63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.
This study's enrollment of 220 is above the median of 100 across 52 interventional studies indexed under Adjustment Disorders.
Browse Adjustment Disorders studies →Valenta Pharm JSC is the lead sponsor of 40 studies on the registry; 18 are open to participants now.
Compared within Adjustment Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Withdrawal Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study drug Ranquilon, tablets, 1 mg, 2 tablets 3 times a day (daily dose - 6 mg/day), daily, for 28 days
Drug: Ranquilon
Placebo, tablets, 2 tablets 3 times a day, daily, for 28 days
Drug: Placebo
Two 1 mg tablets 3 times per day for 28 days
Also known as: GB-115, 6-phenylhexanoyl)glycyl-L-tryptophan amide
Two tablets 3 times per day for 28 days
Change in patient status on the Hamilton Anxiety Rating Scale (HARS): Percentage of patients with a significant, i.e., 50% or greater reduction from baseline, in HARS anxiety levels on Day 29 ± 1
HARS scale includes 14 items, each of which is rated on the Likken scale. Of these, 13 items relate to the manifestation of anxiety in daily life, 14 items relate to the manifestation of anxiety during examinations. The sum of the scores may range from 0 to 56, with scores 0 to 7 corresponding to the absence of anxiety, 8 to 17 to the presence of symptoms of anxiety disorder, 18 to 24 to moderate severity of anxiety disorder, and 25 to 56 to severe severity of anxiety disorder.
Time frame: Day 29 ± 1 of the study
Proportion of patients with a significant, i.e., 50% or greater reduction in HARS anxiety level on Day 15 ± 1 (Visit 2)
HARS scale includes 14 items, each of which is rated on the Likken scale. Of these, 13 items relate to the manifestation of anxiety in daily life, 14 items relate to the manifestation of anxiety during examinations. The sum of the scores may range from 0 to 56, with scores 0 to 7 corresponding to the absence of anxiety, 8 to 17 to the presence of symptoms of anxiety disorder, 18 to 24 to moderate severity of anxiety disorder, and 25 to 56 to severe severity of anxiety disorder.
Time frame: Day 15 ± 1 of the study
Change in HARS anxiety level on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) compared to baseline
HARS scale includes 14 items, each of which is rated on the Likken scale. Of these, 13 items relate to the manifestation of anxiety in daily life, 14 items relate to the manifestation of anxiety during examinations. The sum of the scores may range from 0 to 56, with scores 0 to 7 corresponding to the absence of anxiety, 8 to 17 to the presence of symptoms of anxiety disorder, 18 to 24 to moderate severity of anxiety disorder, and 25 to 56 to severe severity of anxiety disorder.
Time frame: Day 15 ± 1 and Day 29 ± 1 of the study
Proportion of patients with HARS anxiety scores reduced to 17 or less on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3)
HARS scale includes 14 items, each of which is rated on the Likken scale. Of these, 13 items relate to the manifestation of anxiety in daily life, 14 items relate to the manifestation of anxiety during examinations. The sum of the scores may range from 0 to 56, with scores 0 to 7 corresponding to the absence of anxiety, 8 to 17 to the presence of symptoms of anxiety disorder, 18 to 24 to moderate severity of anxiety disorder, and 25 to 56 to severe severity of anxiety disorder.
Time frame: Day 15 ± 1 and Day 29 ± 1 of the study
Time to decrease the HARS anxiety level to a score of 17 or less
HARS scale includes 14 items, each of which is rated on the Likken scale. Of these, 13 items relate to the manifestation of anxiety in daily life, 14 items relate to the manifestation of anxiety during examinations. The sum of the scores may range from 0 to 56, with scores 0 to 7 corresponding to the absence of anxiety, 8 to 17 to the presence of symptoms of anxiety disorder, 18 to 24 to moderate severity of anxiety disorder, and 25 to 56 to severe severity of anxiety disorder.
Time frame: Screening, Day 15 ± 1, Day 29 ± 1 of the study, the end of the study (Day 44 ± 1) or an early termination visit, whichever came first
Proportion of patients with significant and marked improvement as assessed by the physician (Clinical Global Impression - improvement (CGI-i) score 1 or 2) at Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3)
The Clinical Global Impression Scale (CGI) includes two subscales: one for severity of symptoms and one for progression of symptoms with treatment. The first subscale is called Clinical Global Impression - severity (CGI-s) and the second subscale is Clinical Global Impression - improvement (CGI-i). CGI-s includes scores from 0 (healthy) to 7 (very severe); CGI-i includes scores from 1 (marked improvement) to 7 (marked deterioration)
Time frame: Day 15 ± 1 and Day 29 ± 1 of the study
Proportion of patients with a CGI-s score of 1 or 2 as assessed by the physician (healthy or borderline disorder) on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3)
The Clinical Global Impression Scale (CGI) includes two subscales: one for severity of symptoms and one for progression of symptoms with treatment. The first subscale is called Clinical Global Impression - severity (CGI-s) and the second subscale is Clinical Global Impression - improvement (CGI-i). CGI-s includes scores from 0 (healthy) to 7 (very severe); CGI-i includes scores from 1 (marked improvement) to 7 (marked deterioration)
Time frame: Day 15 ± 1 and Day 29 ± 1 of the study
Time to significant or marked improvement - achieving a score of 1 or 2 on the CGI-i scale
The Clinical Global Impression Scale (CGI) includes two subscales: one for severity of symptoms and one for progression of symptoms with treatment. The first subscale is called Clinical Global Impression - severity (CGI-s) and the second subscale is Clinical Global Impression - improvement (CGI-i). CGI-s includes scores from 0 (healthy) to 7 (very severe); CGI-i includes scores from 1 (marked improvement) to 7 (marked deterioration)
Time frame: Screening, Day 15 ± 1, Day 29 ± 1 of the study, or an early termination visit, whichever came first
Time to decrease in severity of condition to 2 points or to 1 point or CGI-s scale
The Clinical Global Impression Scale (CGI) includes two subscales: one for severity of symptoms and one for progression of symptoms with treatment. The first subscale is called Clinical Global Impression - severity (CGI-s) and the second subscale is Clinical Global Impression - improvement (CGI-i). CGI-s includes scores from 0 (healthy) to 7 (very severe); CGI-i includes scores from 1 (marked improvement) to 7 (marked deterioration)
Time frame: Screening, Day 15 ± 1, Day 29 ± 1 of the study, the end of the study (Day 44 ± 1) or an early termination visit, whichever came first
Absolute value of the patient's CGI-i score by Days 15 ± 1 (Visit 2) and 29 ± 1 (Visit 3)
The Clinical Global Impression Scale (CGI) includes two subscales: one for severity of symptoms and one for progression of symptoms with treatment. The first subscale is called Clinical Global Impression - severity (CGI-s) and the second subscale is Clinical Global Impression - improvement (CGI-i). CGI-s includes scores from 0 (healthy) to 7 (very severe); CGI-i includes scores from 1 (marked improvement) to 7 (marked deterioration)
Time frame: Day 15 ± 1 and Day 29 ± 1 of the study
Change in patient severity on the CGI-s scale by Days 15 ± 1 (Visit 2) and 29 ± 1 (Visit 3) compared to baseline
The Clinical Global Impression Scale (CGI) includes two subscales: one for severity of symptoms and one for progression of symptoms with treatment. The first subscale is called Clinical Global Impression - severity (CGI-s) and the second subscale is Clinical Global Impression - improvement (CGI-i). CGI-s includes scores from 0 (healthy) to 7 (very severe); CGI-i includes scores from 1 (marked improvement) to 7 (marked deterioration)
Time frame: Day 15 ± 1 and Day 29 ± 1 of the study
Change in the Multidimensional Fatigue Fatigue Inventory (MFI-20) total score on Day 15 ± 1 (Visit 2) and 29 ± 1 (Visit 3) compared to baseline
The Multidimensional Fatigue Fatigue Inventory (MFI-20) provides a subjective quantitative assessment of the overall severity of asthenia and its various aspects. This scale consists of 20 items reflecting the main components of asthenic syndrome, such as: general asthenia, physical asthenia, mental asthenia, decreased activity and decreased motivation. The patient was given an opportunity to rate the mentioned items to his/her condition on a five-point scale. The score of the scale is the sum of the points of its individual constituent items and can vary in the range from 5 to 25 points. Normally, the total number of points should not exceed 30. If the total score on one of the subscales was higher than 12, this could be a preliminary ground for classifying the condition as an asthenic syndrome
Time frame: Day 15 ± 1 and Day 29 ± 1 of the study
Time to decrease the MFI-20 cumulative score to 30 points or less
The Multidimensional Fatigue Fatigue Inventory (MFI-20) provides a subjective quantitative assessment of the overall severity of asthenia and its various aspects. This scale consists of 20 items reflecting the main components of asthenic syndrome, such as: general asthenia, physical asthenia, mental asthenia, decreased activity and decreased motivation. The patient was given an opportunity to rate the mentioned items to his/her condition on a five-point scale. The score of the scale is the sum of the points of its individual constituent items and can vary in the range from 5 to 25 points. Normally, the total number of points should not exceed 30. If the total score on one of the subscales was higher than 12, this could be a preliminary ground for classifying the condition as an asthenic syndrome
Time frame: Screening, Day 15 ± 1, Day 29 ± 1 of the study, or an early termination visit, whichever came first
Time to decrease the MFI-20 cumulative score by 25% and 50% from baseline
The Multidimensional Fatigue Fatigue Inventory (MFI-20) provides a subjective quantitative assessment of the overall severity of asthenia and its various aspects. This scale consists of 20 items reflecting the main components of asthenic syndrome, such as: general asthenia, physical asthenia, mental asthenia, decreased activity and decreased motivation. The patient was given an opportunity to rate the mentioned items to his/her condition on a five-point scale. The score of the scale is the sum of the points of its individual constituent items and can vary in the range from 5 to 25 points. Normally, the total number of points should not exceed 30. If the total score on one of the subscales was higher than 12, this could be a preliminary ground for classifying the condition as an asthenic syndrome
Time frame: Screening, Day 15 ± 1, Day 29 ± 1 of the study, or an early termination visit, whichever came first
Proportion of patients with a 25% reduction in MFI-20 total score on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) from baseline
The Multidimensional Fatigue Fatigue Inventory (MFI-20) provides a subjective quantitative assessment of the overall severity of asthenia and its various aspects. This scale consists of 20 items reflecting the main components of asthenic syndrome, such as: general asthenia, physical asthenia, mental asthenia, decreased activity and decreased motivation. The patient was given an opportunity to rate the mentioned items to his/her condition on a five-point scale. The score of the scale is the sum of the points of its individual constituent items and can vary in the range from 5 to 25 points. Normally, the total number of points should not exceed 30. If the total score on one of the subscales was higher than 12, this could be a preliminary ground for classifying the condition as an asthenic syndrome
Time frame: Day 15 ± 1 and Day 29 ± 1
Proportion of patients with a 50% reduction in MFI-20 total score on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) from baseline
The Multidimensional Fatigue Fatigue Inventory (MFI-20) provides a subjective quantitative assessment of the overall severity of asthenia and its various aspects. This scale consists of 20 items reflecting the main components of asthenic syndrome, such as: general asthenia, physical asthenia, mental asthenia, decreased activity and decreased motivation. The patient was given an opportunity to rate the mentioned items to his/her condition on a five-point scale. The score of the scale is the sum of the points of its individual constituent items and can vary in the range from 5 to 25 points. Normally, the total number of points should not exceed 30. If the total score on one of the subscales was higher than 12, this could be a preliminary ground for classifying the condition as an asthenic syndrome
Time frame: Day 15 ± 1 and Day 29 ± 1
Proportion of patients with a decrease in their MFI-20 cumulative score to 30 on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3)
The Multidimensional Fatigue Fatigue Inventory (MFI-20) provides a subjective quantitative assessment of the overall severity of asthenia and its various aspects. This scale consists of 20 items reflecting the main components of asthenic syndrome, such as: general asthenia, physical asthenia, mental asthenia, decreased activity and decreased motivation. The patient was given an opportunity to rate the mentioned items to his/her condition on a five-point scale. The score of the scale is the sum of the points of its individual constituent items and can vary in the range from 5 to 25 points. Normally, the total number of points should not exceed 30. If the total score on one of the subscales was higher than 12, this could be a preliminary ground for classifying the condition as an asthenic syndrome
Time frame: Day 15 ± 1 and Day 29 ± 1
Change in Spielberger personality anxiety level on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) compared to baseline
The Spielberger Questionnaire includes a series of statements describing personal and situational anxiety, the answers to which are scored from 1 (least severe or prolonged) to 4 (most severe or prolonged). The patient reads the statements and independently chooses the most appropriate frequency for each statement. When analyzing the results of the self-assessment, you should keep in mind that the overall total for each of the subscales may range from 20 to 80 points. The higher the total score, the higher the level of anxiety (situational or personal).
Time frame: Day 15 ± 1 and Day 29 ± 1
Change in situational anxiety levels on the Spielberger questionnaire on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) compared to baseline
The Spielberger Questionnaire includes a series of statements describing personal and situational anxiety, the answers to which are scored from 1 (least severe or prolonged) to 4 (most severe or prolonged). The patient reads the statements and independently chooses the most appropriate frequency for each statement. When analyzing the results of the self-assessment, you should keep in mind that the overall total for each of the subscales may range from 20 to 80 points. The higher the total score, the higher the level of anxiety (situational or personal).
Time frame: Day 15 ± 1 and Day 29 ± 1
Safety and Tolerability: adverse event (AE) rate
Number and frequency of adverse events (AEs) or serious AEs (SAEs)
Time frame: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 44 ± 1 for each participant
Safety and Tolerability: AEs associated with the study drug
Number and frequency of AEs or SAEs associated with the study drug
Time frame: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 44 ± 1 for each participant
Safety and Tolerability: treatment discontinuation
Percentage of patients who discontinued treatment due to the occurrence of AEs/SAEs
Time frame: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 44 ± 1 for each participant
Safety and Tolerability: vital signs - systolic blood pressure (SBP)
SBP, mmHg
Time frame: Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: vital signs - diastolic blood pressure (DBP)
DBP, mmHg
Time frame: Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: vital signs - respiratory rate (RR)
RR, breaths per minute
Time frame: Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: vital signs - heart rate (HR)
HR, beats per minute
Time frame: Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: vital signs - body temperature
Body temperature, centigrade scale
Time frame: Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: physical examination results
Physical examination will follow the general rules of internal medicine: general examination, examination of mucous membranes and skin, including palpation of lymph nodes, evaluation of the musculoskeletal system, palpation, percussion, and auscultation of the main organ systems (cardiovascular, respiratory, digestive, and urinary systems) will be performed sequentially
Time frame: Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute)
Time frame: Screening, day 29, or on the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms)
Time frame: Screening, day 29, or on the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms)
Time frame: Screening, day 29, or on the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc)
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms)
Time frame: Screening, day 29, or on the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: complete blood count - hemoglobin
Hemoglobin, g/dL
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: complete blood count - hematocrit
Hematocrit, %
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: complete blood count - red blood cells
Red blood cells, 10\^6/uL
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: complete blood count - white blood cells
White blood cells, 10\^3/uL
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: complete blood count - platelets
Platelets, 10\^3/uL
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: complete blood count - erythrocyte sedimentation rate
Erythrocyte sedimentation rate, mm per hour
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: complete blood count - lymphocytes
Lymphocytes, %
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: complete blood count - eosinophils
Eosinophils, %
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: complete blood count - monocytes
Monocytes, %
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: complete blood count - basophils
Basophils, %
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: complete blood count - neutrophils
Neutrophils, % (segmented and stab)
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: blood test results - total cholesterol
Total cholesterol in blood serum, mmol/L
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: blood test results - total protein
Total protein in blood serum, g/L
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: blood test results - glucose
Glucose in blood serum, mmol/L
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: blood test results - creatinine
Creatinine in blood serum, umol/L
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: blood test results - alanine transaminase (ALT)
ALT in blood serum, U/L
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: blood test results - aspartate transaminase (AST)
AST in blood serum, U/L
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: blood test results - total bilirubin
Total bilirubin in blood serum, umol/L
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: blood test results - direct bilirubin
Direct bilirubin in blood serum, umol/L
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: blood test results - alkaline phosphatase (ALP)
ALP in blood serum, U/L
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: blood test results - urea
Urea in blood serum, mmol/L
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: urinalysis - color
Color of the urine (yellow, brown, etc.)
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: urinalysis - transparency
Transparency of the urine (transparent/cloudy)
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: urinalysis - specific gravity
Specific gravity of the urine
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: urinalysis - pH
pH of the urine
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: urinalysis - glucose
Glucose in the urine (mmol/L)
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: urinalysis - protein
Protein in the urine (g/L)
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: urinalysis - ketones
Ketones in the urine (mmol/L)
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Safety and Tolerability: urinalysis - urobilinogen
Urobilinogen in the urine (umol/L)
Time frame: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation
Plan to share: Undecided
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Ran from Oct 2022 to primary completion in Nov 2022, 1 month.
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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