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TML-6 for Alzheimer’s Disease

Phase 1

Recruiting

Research Sponsored by Merry Life Biomedical Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy male and female volunteers

Female subjects of child-bearing potential show negative pregnancy test results at screening and admission.

Must not have

Female subjects who are lactating or with a positive pregnancy test at the screening visit and/or admission.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Summary

"This trial will test the safety and effectiveness of TML-6 on different dosing levels and with or without food to see how the body processes the medication."

Who is the study for?

This trial is for healthy adults and elderly volunteers who are interested in helping to find new treatments for Alzheimer's disease. Participants should not have any serious health issues that could interfere with the study.

What is being tested?

The study is testing TML-6, a potential treatment for Alzheimer's. It will look at how people handle different doses, how food affects it, and what happens to TML-6 in the body over time compared to a placebo.

What are the potential side effects?

Since this is an early-phase trial assessing safety and tolerability, specific side effects of TML-6 are unknown but may include typical drug-related reactions such as nausea, headaches, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a healthy volunteer.

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I am of child-bearing age and my pregnancy tests are negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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My blood pressure is higher than 140/90 mmHg, even with medication.

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I haven't been diagnosed with a new illness in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

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Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TML-6 GranulesExperimental Treatment1 Intervention

This 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.

Group II: PlaceboPlacebo Group1 Intervention

Placebo

0 / 5Eligibility criteria met