SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects
NCT05476107 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2022-07-27
Summary
Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
AMT-126
Single or daily dosing at doses A, B, C, D, E, F; G, H, and I
- DRUG
-
Single or daily dosing at doses A, B, C, D, E, F; G,H, and I
- OTHER
-
Radioactive Tablet (Part 2 Only)
Single dose in two periods in Part 2 (optional)
Sponsors & Collaborators
-
Applied Molecular Transport
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-02-26
- Primary Completion
- 2022-03-26
- Completion
- 2022-03-26
Countries
- United Kingdom
Study Locations
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