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.
Full record on ClinicalTrials.gov (NCT ID NCT06562114).
A Phase 1, Safety, Tolerability, Single-ascending Dose, Multiple-ascending Dose, Food Effect, and Pharmacokinetic Study of TML-6 in Healthy Volunteers
Merry Life Biomedical Co., Ltd. · Interventional, Randomized
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Study context
Single-site study
Overview
Results summary
None
Outcome data
| Endpoint | Type | Result | Significance |
|---|---|---|---|
| Safety and tolerability: Incidence of Serious Adverse Events (SAEs) and treatment-related adverse events | Primary | None | None |
| Plasma PK: Maximum Plasma Concentration (Cmax) will be assessed for part 1-5 study | Secondary | None | None |
| Plasma PK: Area Under the Curve (AUC) will be assessed for part 1-5 study | Secondary | None | None |
| Plasma PK: Time to reach peak plasma concentration (Tmax) will be assessed for part 1-5 study | Secondary | None | None |
| Plasma PK: Terminal half-life (T1/2) will be assessed for part 1-5 study | Secondary | None | None |
| Plasma PK: Peak plasma concentration at steady state (Cmax,ss) will be assessed for part 4 and 5 study | Secondary | None | None |
| Plasma PK: Area under the concentration-time curve (AUC0→24,ss and AUC0→τ,ss) will be assessed for part 4 and 5 study | Secondary | None | None |
| Plasma PK: Time to reach peak concentration at steady state (Tmax,ss) will be assessed for part 4 and 5 study | Secondary | None | None |
| Plasma PK: Terminal half-life at steady state (T1/2,ss) will be assessed for part 4 and 5 study | Secondary | None | None |
| Plasma PK: Accumulation ration (Rac) will be assessed for part 4 and 5 study | Secondary | None | None |
| CSF PK: Maximum observed concentration in CSF at steady state (CSF Cmax,ss) will be assessed for part 5 study | Secondary | None | None |
| CSF PK: Time to reach peak concentration in CSF at steady state (Tmax,ss) will be assessed for part 5 study | Secondary | None | None |
| 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 | Secondary | None | None |
| CSF PK: Ratio of CSF AUC0→24,ss to Plasma AUC0→24,ss for part 5 study, if applicable | Secondary | None | None |
Full results record on ClinicalTrials.gov.
Study design
- Phase
- Phase 1
- Study type
- Interventional
- Allocation
- Randomized
- Masking
- Double-blind
- Intervention model
- Sequential assignment
- Primary purpose
- Treatment
- Enrollment (final)
- 72 participants
- Started
- July 2024
- Actually completed
- August 2025
Recruitment criteria
Age range: 18–80 · Sex: All · Healthy volunteers: Accepts
Locationsi
1 site participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.
Parexel International — Glendale, California (United States)
Sources
ClinicalTrials.gov — NCT06562114
Trial registry · primary record