A Phase 1/2 interventional study of EN001 and EN001 in Sarcopenia, sponsored by ENCell. Not yet recruiting at 1 site in South Korea. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by ENCell · Phase 1/2, Interventional, and Treatment
Among 40 studies in Sarcopenia with a site in Korea, Republic of — 13 open to participants now, 15 under way, none of them phase 3. Sarcopenia · Korea, Republic of.
Among the 40 studies in Sarcopenia with a site in Korea, Republic of, this one is the 8th largest by planned enrollment of the 29 interventional ones that give a count, is the only one that started in 2027, is the only one in phase 1/2, reaches primary completion later than 14 of the 14 other live ones, and was the 40th registered.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
Browse Sarcopenia studies →13 of the 40 studies in Sarcopenia with a site in Korea, Republic of are open now. Recruiting first, the newest first:
Pusan National University Yangsan Hospital · Sites in Korea, Republic of
Ages 50–79 · Healthy volunteers
Pluto Inc. · Sites in Korea, Republic of
Ages 65+
Animuscure Inc. · Sites in Korea, Republic of
Ages 65+
Seoul National University Bundang Hospital · Sites in Korea, Republic of
Ages 20–90 · Healthy volunteers
Seoul National University Hospital · Sites in Korea, Republic of
Ages 40–100
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 247 Sarcopenia studies recruiting now, 153 (62%) set no upper age limit and 33 (13%) stop at 75 or younger; 9 take children under 18; 65 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 4 3
First in 2009; this study’s year is marked. 1 started in 2027.
This study's planned enrollment of 132 is above the median of 60 across 855 interventional studies indexed under Sarcopenia.
Median enrollment 80 across the 29 interventional studies, 150 across the 11 observational. Of the 19 that completed or were terminated, 2 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 40 have an industry lead sponsor. The 10 most frequent:
ENCell is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
ENCell has 1 study filed under Sarcopenia — fewer than ten, so there is no comparison to draw.
3 of the studies in Sarcopenia with a site in Korea, Republic of that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07634523Seoul National University HospitalBranched Chain Amino Acids for Sarcopenia in Patients Undergoing Total Knee Arthroplasty | 2027-05-31 |
| NCT07749118Pusan National University Yangsan HospitalHB05P on Muscle Health | 2027-06-29 |
| NCT07390552Pluto Inc.A Study of PLH-2301 in Subjects With Sarcopenia | 2027-06-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 40 studies in Sarcopenia with a site in Korea, Republic of, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of EN001 in Patients with Sarcopenia
This clinical trial is a multicenter study consisting of two stages (Phase 1 and Phase 2). Phase 1 is designed with a 3+3 dose escalation design to evaluate the safety, including tolerability, of EN001 and explore efficacy. Phase 2 will evaluate the efficacy and safety of EN001 at the recommended Phase 2 dose (RP2D), as determined in Phase 1, compared with placebo.
--Phase 1 The study was designed using the traditional 3+3 dose escalation method to confirm the maximum tolerated dose (MTD) and determine the recommended phase 2 dose (RP2D).
Dose increase is carried out until the maximum tolerated dose (MTD) is confirmed at the high dose (Cohort 3), which is the maximum planned dose (MPD), or at a lower dose. The maximum tolerated dose (MTD) is defined as the highest dose at which the incidence of dose limiting toxicity (DLT) is lower than 33%. To determine the maximum tolerated dose (MTD), 3-6 test subjects from each dose cohort are enrolled and EN001 is administered three times at 4-week intervals, and dose-limiting toxicity (DLT) is evaluated until 4 weeks (visit 5).
Safety data for EN001 confirmed by the end of each Cohort (i.e., the end of the dose-limiting toxicity (DLT) evaluation of the last dosed subject in the Cohort) are comprehensively reviewed to determine all matters related to dose, such as increase or decrease in dose, and finally the recommended phase 2 dose (RP2D) is determined.
-- Phase 2 The Phase 2 is a randomized, double-blind, placebo-controlled clinical trial. Eligible subjects will be randomly assigned in a 1:1:1 ratio to Study Group 1 (EN001 Low dose, which is the recommended Phase 2 dose [RP2D]), Study Group 2 (EN001 High dose), or the placebo control group. The efficacy and safety of EN001 will be evaluated in comparison with placebo.
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.
1) Male or Female aged 60 years or older at the time of providing written consent. : Female subjects must meet one of the following criteria for women* :
Postmenopausal women:
2) Individuals diagnosed with sarcopenia at the time of screening, based on the diagnostic criteria in Section 15.1 of the Asian Working Group for Sarcopenia(AWGS) 2019 guidlines, meeting (1) or (2) together with (3):
6) Individuals meeting the following laboratory test criteria at the time of screening and baseline:
7) Men who have agreed to use the appropriate method(s), as specified in the protocol, from the date of signing the form through the end-of-study visit
Appropriate contraception is defined as follows and is achieved by applying one or more methods of contraception :
Abstinence: Absolute abstinence. If, in the examiner's judgment, the subject's age, occupation, lifestyle, or sexual orientation warrants contraception, strict abstinence from sexual intercourse is also acceptable. However, periodic abstinence (e.g. Karenda method, ovulation method, symptomatic temperature method), abstinence, and external vaginal ejaculation are not recognized as appropriate contraceptive methods.
8) Individuals who(or whose legally authorized representative) have voluntarily agreed to participate in this clinical trial.
Exclusion Criteria:
1)Those with the following comorbidities confirmed at the time of screening and baseline
Any one of the serum virus tests (, anti-HBc, anti-, Ag/Ab) is positive
2) Subjects with a confirmed history of the following treatments:
Any of the following medications that may affect muscle at screening:
6) Those who are deemed inappropriate to participate in clinical trials according to the judgment of the investigator*
Examples of inappropriate reasons include, but are not limited to, the following:
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
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.
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.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
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.
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.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
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.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EN001 Low dose
Drug: EN001
EN001 Medium dose
Drug: EN001
EN001 High dose
Drug: EN001
EN001 Low dose
Drug: EN001
EN001 High dose
Drug: EN001
EN001 Placebo
Drug: EN001 Placebo
\- Phase1-Cohort 1: EN001 Low dose administered intravenously (IV) 3 times at 4 week intervals.
Also known as: EN001(Allogeneic early-passage Wharton's jelly-derived mesenchymal stem cells(WJ-MSCs)
-Phase2-Cohort 2 : EN001 Medium dose administered intravenously (IV) 3times at 4 week intervals.
Also known as: EN001(Allogeneic early-passage Wharton's jelly-derived mesenchymal stem cells(WJ-MSCs) )
-Phase1-Cohort 3 : EN001 High dose administered intravenously (IV) 3times at 4 week intervals.
Also known as: EN001(Allogeneic early-passage Wharton's jelly-derived mesenchymal stem cells(WJ-MSCs) )
-Phase2-Cohort 1 : EN001 Low dose(Recommended Phase 2 Dose\[RP2D\] of EN001) administered intravenously (IV) 3times at 4 week intervals.
Also known as: EN001(Allogeneic early-passage Wharton's jelly-derived mesenchymal stem cells(WJ-MSCs) )
-Phase2-Cohort2 : EN001 High dose(Recommended Phase 2 Dose\[RP2D\] of EN001) administered intravenously (IV) 3times at 4 week intervals.
Also known as: EN001(Allogeneic early-passage Wharton's jelly-derived mesenchymal stem cells(WJ-MSCs) )
-Phase2-Placebo : EN001 Placebo administered intravenously (IV) 3times at 4 week intervals.
Also known as: EN001(Allogeneic early-passage Wharton's jelly-derived mesenchymal stem cells(WJ-MSCs) )
[Phase1] Dose limiting toxicity (DLT) and adverse drug reactions related to discontinuation of investigational product administration
Present the frequency and percentage of dose-limiting toxicity (DLT) occurrence across dose cohorts, along with detailed information on the types of DLTs. Adverse events related to discontinuation of clinical investigational drug administration, discontinuation of clinical investigational drug administration Regarding related adverse drug reactions, the number of subjects in each cohort, incidence rate (%), and Two-sided 95% confidence intervals and number of occurrences are presented.
Time frame: Up to 12 weeks
[Phase2] Change from baseline in the SPPB(Short Physical Performance Battery) at Week 24
For all efficacy outcome measures, descriptive statistics (number of subjects, mean, standard deviation, median, minimum, and maximum) will be presented by treatment group and assessment time point, along with two-sided 95% confidence intervals.
Time frame: at Week 24
[Phase1, Phase2] SPPB(Short Physical Performance Battery) score change
Present the subject count, mean, standard deviation, median, minimum, and maximum for the changes at each time point within each dosage group.
Time frame: At 4,8,12, 18, and 24 weeks compared to baseline(Visit2)
[Phase1, Phase2] Change in handgrip strength
Present the subject count, mean, standard deviation, median, minimum, and maximum for the changes at each time point within each dosage group.
Time frame: At 4,8,12, 18, and 24 weeks compared to baseline(Visit2)
[Phase1, Phase2] Change in time to complete the 5-Times Chair Stand Test
Present the subject count, mean, standard deviation, median, minimum, and maximum for the changes at each time point within each dosage group.
Time frame: At 4,8,12, 18, and 24 weeks compared to baseline(Visit2)
[Phase1, Phase2] Change in 6-Minute Walk Test (6MWT) distance
Present the subject count, mean, standard deviation, median, minimum, and maximum for the changes at each time point within each dosage group.
Time frame: At 4,8,12, 18, and 24 weeks compared to baseline(Visit2)
[Phase1, Phase2] Change in Appendicular Skeletal Muscle Mass (ASM) measured by DXA
Present the subject count, mean, standard deviation, median, minimum, and maximum for the changes at each time point within each dosage group.
Time frame: At 12 and 24 weeks compared to baseline(Visit2)
[Phase1, Phase2] SarQoL domain and total score change
Present the subject count, mean, standard deviation, median, minimum, and maximum for the changes at each time point within each dosage group.
Time frame: At 12 and 24 weeks compared to baseline(Visit2)
[Phase1, Phase2] Change in Skeletal Muscle Mass Index(SMI)
Present the subject count, mean, standard deviation, median, minimum, and maximum for the changes at each time point within each dosage group.
Time frame: At 24 weeks compared to baseline(Visit2)
[Phase1, Phase 2] Adverse Event
By group that Number of subjects, incidence rate (%), confidence interval (two-sided 95%), presents the number of occurrences. Additional, The pre-treatment adverse event that occurred before administration of clinical trial drugs is presented in detail.
Time frame: Up to 24weeks. However, adverse drug reactions that persist at the end of the clinical trial will be followed up until the possible adverse reactions are resolved or it is determined that further follow-up is not meaningful.
[Phase1, Phase2] Vital sign
Number of participants with clinically significant abnomalities in vital signs after EN001 administration. Vital Signs include blood pressure (mmHg), pulse (times/minute), respiratory rate (times/minute), and body temperature (℃) and will be assessed. By cohort and visit, present continuous variables with subject count, mean, standard deviation, median, minimum, and maximum. For categorical variables, provide shift table.
Time frame: Up to 24 weeks
[Phase1, Phase2] Laboratory examination
Number of participants with clinically significant abnormalities in Laboratory parameters after EN001 administration. Hematological tests, Blood chemical tests, Blood coagulation test, Urine test, Serum virus test. It is conducted through blood and urine collection, and the PI checks whether the test results are normal, abnormal, and clinically significant.
Time frame: Up to 24 week. Serum virus testing is performed only during screening. At Baseline, Week4 and Week8, hematological tests, blood chemical tests, D-dimer are performed before and within 4 hours after administration of the IP.
[Phase1, Phase2] electrocardiography
Number of participants with clinically significant abnormalities in electrocardiography after EN001 administration. Based on the PR Interval, QRS Duration, QTc Interval and QTcF Interval, PI checks whether the test results are normal, abnormal, and clinically significant. by cohort and visit, present continuous variables with subject count, mean, standard deviation, median, minimum, and maximum. For categorical variables, provide shift table.
Time frame: At Baseline, Week 4, Week 8, Week 12, Week 24
[Phase1, Phase2] X-ray
by cohort and visit, present continuous variables with subject count, mean, standard deviation, median, minimum, and maximum. For categorical variables, provide shift table.
Time frame: Before administration of investigational product at Baseline, within 4 hours after completion of administration, and at Weeks 4, 8, 12, and 24
[Phase1, Phase2] Physical Examinations
Number of participants with clinically significant abnormalities in Physical Examinations after EN001 administration. Based on general appearance, head,ears/eyes/nose/throat, cardiovascular, respiratory, abdomen, skin, lymph nodes, extremities, musculoskeletal and neurologic, PI checks whether the test results are normal, abnormal, and clinically significant. By cohort and visit, present continuous variables with subject count, mean, standard deviation, median, minimum, and maximum. For categorical variables, provide shift table.
Time frame: Up to 24 weeks
Start is estimated for Mar 2027; primary completion for Oct 2029, 31 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: EN001
ENCell