A Phase 1 Safety and Tolerability Study of TML-6 in Healthy and Elderly Volunteers for Alzheimer's Disease Treatment
NCT06562114 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2025-10-30
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.
Conditions
- Healthy
Interventions
- DRUG
-
TML-6 Granules
Administered orally
- DRUG
-
Administered orally
Sponsors & Collaborators
-
Merry Life Biomedical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-07-11
- Primary Completion
- 2025-07-18
- Completion
- 2025-08-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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