NCT05476107

SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects

A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Applied Molecular Transport · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	AMT-126	Single or daily dosing at doses A, B, C, D, E, F; G, H, and I
DRUG	Placebo	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)

Timeline

• Start date: 2021-02-26
• Primary completion: 2022-03-26
• Completion: 2022-03-26
• First posted: 2022-07-27
• Last updated: 2022-07-27

Locations

1 site across 1 country: United Kingdom