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HealthyPhase 1NCT06562114

A Phase 1 Safety and Tolerability Study of TML-6 in Healthy and Elderly Volunteers for Alzheimer's Disease Treatment

A Phase 1 study testing TML-6 Granules in people with Healthy, run by Merry Life Biomedical Co., Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, tolerability, single-ascending dose (SAD), multiple-ascending dose (MAD), food effect, and pharmacokinetic (PK) Study of TML-6. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
TML-6 Granules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteUnited States
Study dates
11 Jul 2024to 15 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy male and female volunteers
  • For Parts 1, 2, and 4 (Cohorts 1-5 and 7-8): Subject's age is ≥18 years old and ≤55 years old at screening.
  • For Parts 3 and 5 (Cohorts 6 and 9): Subject's age is ≥60 years old and ≤80 years old at screening.
  • For Parts 1, 2, and 4 (Cohorts 1-5 and 7-8): Subjects whose body mass index (BMI) at screening is within a range of ≥18.5 kg/m2 and <30.0 kg/m2 For Parts 3 and 5 (Cohorts 6 and 9): Subjects whose BMI <30.0 kg/m2 Note: BMI = Body weight (kg) / [Height (m)]2; Body weight is not less than 50 kg at screening and admission.
  • Subjects who are deemed to be satisfactory health by the investigator through an assessment of their medical history, physical examinations, and routine laboratory tests.
  • Female subjects of child-bearing potential show negative pregnancy test results at screening and admission.
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  • Female subjects of child-bearing potential, committing to practicing sexual abstinence or using and continue to use 2 highly effective contraceptives of birth control for at least 30 days prior to screening (that period will extend to 90 days for oral contraceptive use) and for at least 30 days after the last dose of investigational product (IP).
  • For a subject to be considered not to be of child-bearing potential, she must have been amenorrheic for at least 12 months with confirmed follicle-stimulating hormone (FSH) level (within postmenopausal range) at screening, or must have had a hysterectomy, a bilateral tubal ligation, and/or a bilateral oophorectomy (as determined by the medical history).
  • The male partner of a female study subject with childbearing potential must use a condom and ensure that his partner uses a highly effective contraception as outlined below.
  • The highly effective contraception methods include:
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
  • Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
  • Combination of the following listed methods (d.1+d.2):
  • d.1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception, intrauterine device (IUD), or intrauterine system (IUS).
  • d.2. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps).
  • Subjects must demonstrate willingness to comply with all requirements, instructions and restrictions stated in the protocol, and must provide the written informed consent form after thorough understanding.
  • -

Who cannot join

  • Subjects with any properly diagnosed disease within 30 days prior to the first dose of the IP.
  • Subjects who have a QTcF interval >450 msec (male) or >470 msec (female) (Fridericia's correction) at screening. The assessment may be repeated once during the screening period.
  • Systolic blood pressure (SBP) >140 mmHg or diastolic blood pressure (DBP) >90 mmHg at screening and admission, irrespective of anti-hypertensive medication status for the subject. The assessments may be repeated for confirmation after resting for approximately 10 to 30 minutes.
  • Any laboratory values with the following deviations at screening and admission. The laboratory test may be repeated once during the screening period and Day -1.
  • White blood cell count (WBC) < 3000/μL
  • Hemoglobin < 10 g/dL
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  • Platelet count < 100000/μL
  • Creatinine > upper limit of normal (ULN)
  • Alanine Aminotransferase (ALT) > ULN
  • Aspartate Aminotransferase (AST) > ULN
  • Total bilirubin > ULN of the reference range * If agreement is obtained per the investigator's discretion, exceptions may be made for isolated ALT or AST elevation <1.5× ULN and bilirubin values that are above the ULN for subject has an underlying diagnosis of Gilbert's syndrome.
  • Subjects who have been tested positive for the following tests:
  • Human immunodeficiency virus (HIV)
  • Hepatitis B virus (HBV)
  • Hepatitis C virus (HCV)
  • Female subjects who are lactating or with a positive pregnancy test at the screening visit and/or admission.
  • Subjects had a history of substance use disorders according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V) criteria.
  • Subjects with positive urine drug test (including cotinine detection) or positive blood alcohol test at screening and on Day -1 (and on Day 15+ in Cohort 2).
  • Subjects with underlying medical, mental, or psychological conditions that may impede study compliance, or, at the discretion of the investigator, preclude participation in the study.
  • The medical history indicates contraindications or hypersensitivity to the use of test medications [TML-6 or any components of the IP].
  • Subjects took any of the following systemically-absorbed medications in the specified durations:
  • Any medications (excluding vitamins, food supplements, and hormonal contraceptives for birth control) within 14 days prior to the first dose of the IP, unless in the opinion of the investigator and sponsor, the medication will not interfere with the study or compromise subject's safety.
  • Any known enzyme inducers/inhibitors or agents that significantly alter hepatic or renal clearance (e.g., erythromycin, cimetidine, barbiturates, phenothiazine, clarithromycin, troleandomycin, ketoconazole, miconazole, fluconazole, itraconazole) within 30 days prior to the first dose of the IP.
  • Subjects had participated in investigational drug trials and took any investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the first dose of the IP.
  • Subjects had blood loss or blood donation of more than 250 and 500 mL within 60 and 90 days, respectively prior to the first dose of the IP.
  • Subjects who cannot stop caffeine-intake for 48 hours prior to the first study dose and during the entire study period.
  • Subjects who are smokers or former smokers who have used nicotine-containing products within 3 months prior to the first dose of the IP.
  • Unwilling or unable to comply with the lifestyle instructions described in the protocol.
  • Subjects appears to have poor venous access.
  • Subjects have any other condition which, in the opinion of the investigator, precludes the subject's participation in the study.
  • Additional exclusion criteria for the healthy adult subjects in Cohorts 1-5 and 7-8:
  • Subjects with a clinically significant hematological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, pulmonary, immunologic, metabolic, urologic disorder, and/or malignancy as judged by the investigator; subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism, and excretion of drugs; subjects who has had any previous gastrointestinal surgery, except appendectomy if performed >90 days prior to the first dose of the IP.
  • Additional exclusion criteria for the healthy elderly subjects in Cohorts 6 and 9:
  • Subjects with a clinically significant hematological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, pulmonary, immunologic, metabolic, urologic disorder, and/or malignancy that is not well managed and stable, as judged by the investigator; subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism and excretion of drugs; subjects who has had any previous gastrointestinal surgery, except appendectomy if performed >90 days prior to the first dose of the IP.
  • Subjects with estimated Glomerular Filtration Rate (eGFR, calculated based on Cockcroft-Gault formula) of <60 mL/min/1.73 m2 during screening period. If the eGFR exceeds the limits above, the assessment may be repeated once during the screening period.
  • Additional exclusion criteria for the subjects in Cohorts 7-9:
  • If the subject has history of suicidal attempt as an adult or suicide ideation in the past year that resulted in pharmacologic treatment or hospitalization, the subject will be excluded if he/she meets any of the following criteria.
  • Answer of "yes" on items 4 or 5 of the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening if the ideation occurred in the previous 6 months.
  • Answer of "yes" on any item of the Suicidal Behavior section of the C-SSRS, except for the Non-Suicidal Self injurious Behavior if this behavior occurred in the previous 2 years.
  • Additional exclusion criteria for the subjects in Cohort 9:
  • The subject with clinically significant abnormal finding in the lumbar X-ray examination that is considered incompatible with lumbar puncture (LP) by the investigator at screening.
  • The subject has had CSF collection performed within 30 days prior to Day -1.
  • The subject has a history of clinically significant back pain and/or injury (e.g., clinically significant degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with LP, as judged by the investigator.
  • The subject has developed signs and symptoms of spinal radiculopathy, including lower extremity pain and paresthesias.
  • The subject has evidence or history of significant active bleeding or coagulation disorder or have received drugs that affect coagulation or plate function within 14 days prior to LP procedure.
  • The subject has a local infection at the puncture site.
  • The subject has any focal neurological deficit that might suggest an increase in intracranial pressure.
  • The subject has any abnormal finding on ophthalmological assessment/fundoscopy indicative of raised intracranial pressure (i.e., optic disc swelling/edema, or uncontrolled hypertensive retinopathy).
  • The subject has abnormal coagulation tests (prothrombin time [PT]/international normalized ratio [INR], and partial thromboplastin time [PTT]) at screening. The assessment may be repeated once during the screening period.
  • The subject regularly suffers from moderate-to-severe headaches requiring analgesics.
  • Subject's medical history shows hypersensitivity to the anesthetic, or its derivatives used during CSF collection or any medication used to prepare the area of LP procedure.
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Parexel International

    Glendale, California, 91206

Other trials in United States

About this study

Official title: A Phase 1, Safety, Tolerability, Single-ascending Dose, Multiple-ascending Dose, Food Effect, and Pharmacokinetic Study of TML-6 in Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability, single-ascending dose (SAD), multiple-ascending dose (MAD), food effect, and pharmacokinetic (PK) Study of TML-6.

Conditions
Healthy
Being tested
TML-6 Granules, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TML-6 GranulesDrug

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT06562114
Study groupRoleWhat they receive
TML-6 GranulesExperimentalThis study consists of 5 parts, Part 1 (SAD): 5 cohorts of subjects are planned to be orally dosed, ranging from 100 mg - 1000 mg. Part 2 (Food effect): All subjects in Cohort 2 of Part 1 will constitute Period 1 of Part 2 and will move to Period 2 to receive the same Investigational Product (IP) dose as in Period 1. Part 3 (Elderly): One cohort of elderly subjects will receive a single dose of IP. A dose level of IP within the safe range defined in the Part 1 SAD study will be chosen Part 4 (MAD): 2 cohorts of subjects are planned to be orally dosed once daily for 7 consecutive days, ranging from 400 mg - 800 mg. Part 5 (MAD+Cerebrospinal Fluid, CSF PK): One cohort of elderly subjects will receive orally once daily for 7 consecutive days of IP. The dose level of IP defined in the Part 4 MAD study will be chosen.
Receives: Drug: TML-6 Granules
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability: Incidence of Serious Adverse Events (SAEs) and treatment-related adverse events

    Incidence of SAEs and treatment-related severe AEs

    Measured: All subjects at each dose level complete the 3-day safety assessments post-dose for part 1-3 study and all subjects at each dose level complete the 8-day safety assessments post the first dose for part 4 & 5 study

Secondary outcomes (13)

  1. Plasma PK: Maximum Plasma Concentration (Cmax) will be assessed for part 1-5 study

    Part 1-5 study (plasma PK):

    • Peak plasma concentration (PCmax,) [ng/mL] of TML-6

    Part 2 only:

    Comparative bioavailability analysis in the extent of the peak concentration (PCmax)[ng/mL] of TML-6 under fed or fasting condition

    Measured: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, and 48 hours postdose

  2. Plasma PK: Area Under the Curve (AUC) will be assessed for part 1-5 study

    Part 1-5 study (plasma PK):

    The TML-6 plasma concentration-time profile will be established and Area under the concentration-time curve (AUC0→24, AUC0→last, 0→inf, and %AUCextrap)[ng*h/mL] of TML-6

    Part 2 only:

    Comparative bioavailability analysis in the extent of total exposure by area under the curve (AUC0→last and AUC0→inf) [ng*h/mL] of TML-6 under fed or fasting condition

    Measured: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, and 48 hours postdose

  3. Plasma PK: Time to reach peak plasma concentration (Tmax) will be assessed for part 1-5 study

    Part 1-5 study (plasma PK):

    • Time to reach peak plasma concentration (Tmax)[hours, or h] of TML-6

    Part 2 only:

    Comparative bioavailability analysis in the extent of the Time to reach peak concentration (Tmax)[hours, or h] of TML-6 under fed or fasting condition

    Measured: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, and 48 hours postdose

  4. Plasma PK: Terminal half-life (T1/2) will be assessed for part 1-5 study

    Part 1-5 study (plasma PK):

    • Terminal half-life (T1/2) [hour] of TML-6

    Part 2 only:

    Comparative bioavailability analysis in the extent of Terminal half-life (T1/2) [hour] of TML-6 under fed or fasting condition

    Measured: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, and 48 hours postdose

  5. Plasma PK: Peak plasma concentration at steady state (Cmax,ss) will be assessed for part 4 and 5 study

    Part 4-5 study (plasma PK):

    • Peak plasma concentration at steady state (Cmax,ss)[ng/mL] of TML-6

    Measured: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose

  6. Plasma PK: Area under the concentration-time curve (AUC0→24,ss and AUC0→τ,ss) will be assessed for part 4 and 5 study

    Part 4-5 study (plasma PK):

    • Area under the concentration-time curve at steady state (AUC0→24,ss and AUC0→τ,ss) [ng*h/mL] of TML-6

    Measured: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose

  7. Plasma PK: Time to reach peak concentration at steady state (Tmax,ss) will be assessed for part 4 and 5 study

    Part 4-5 study (plasma PK):

    • Time to reach peak concentration at steady state (Tmax,ss) [hours, or h] of TML-6

    Measured: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose

  8. Plasma PK: Terminal half-life at steady state (T1/2,ss) will be assessed for part 4 and 5 study

    Part 4-5 study (plasma PK):

    • Terminal half-life at steady state (T1/2,ss) [hour] of TML-6

    Measured: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose

  9. Plasma PK: Accumulation ration (Rac) will be assessed for part 4 and 5 study

    Part 4-5 study (plasma PK):

    • Accumulation ration (Rac) [unit of ratio] of TML-6

    Measured: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose

  10. CSF PK: Maximum observed concentration in CSF at steady state (CSF Cmax,ss) will be assessed for part 5 study

    CSF PK at steady-state (after the final dose)

    • Maximum observed concentration in CSF at steady state (CSF Cmax,ss)[ng/mL] of TML-6

    Measured: on Day 7 (prior to dosing, 0.5, 1, 2, 4, 8, 12, 16 hours after dosing) and Day 8 (24 hours after dosing)

  11. CSF PK: Time to reach peak concentration in CSF at steady state (Tmax,ss) will be assessed for part 5 study

    CSF PK at steady-state (after the final dose),

    • Time to reach peak concentration in CSF at steady state (Tmax,ss) [hours, or h] of TML-6

    Measured: on Day 7 (prior to dosing, 0.5, 1, 2, 4, 8, 12, 16 hours after dosing) and Day 8 (24 hours after dosing)

  12. CSF PK: Area under the CSF concentration-time curve from 0 to the 24 hours at steady state (CSF AUC0→24,ss) will be assessed for 5 study, if applicable

    CSF PK at steady-state (after the final dose),

    • Area under the CSF concentration-time curve from 0 to the 24 hours at steady state (CSF AUC0→24,ss)[ng*h/mL] of TML-6, if applicable

    Measured: on Day 7 (prior to dosing, 0.5, 1, 2, 4, 8, 12, 16 hours after dosing) and Day 8 (24 hours after dosing)

  13. CSF PK: Ratio of CSF AUC0→24,ss to Plasma AUC0→24,ss for part 5 study, if applicable

    • Ratio of CSF AUC0→24,ss to Plasma AUC0→24,ss[unit of ratio] of TML-6, if applicable

    Measured: on Day 7 (prior to dosing, 0.5, 1, 2, 4, 8, 12, 16 hours after dosing) and Day 8 (24 hours after dosing)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2024
  2. Study start11 Jul 2024
  3. Primary completion18 Jul 2025
  4. Study completion15 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06562114
Sponsor's protocol ID
MELTMLZ20220315
Status last verified
Aug 2025
First submitted
13 Aug 2024
Last updated
30 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TML-6 Granules in people with Healthy, run by Merry Life Biomedical Co., Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability: Incidence of Serious Adverse Events (SAEs) and treatment-related adverse events (time frame: All subjects at each dose level complete the 3-day safety assessments post-dose for part 1-3 study and all subjects at each dose level complete the 8-day safety assessments post the first dose for part 4 & 5 study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06562114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.

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