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

Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: AMT-126; Drug: Placebo; Other: Radioactive Tablet (Part 2 Only)

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Ruddington, Nottingham, United Kingdom, NG11 6JS
      • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

PART 1 & 2 (Healthy Volunteers)

Inclusion Criteria:

• Healthy male subjects and female subjects of NOCBP.
• Between 18 and 55 years of age (Part 1) and 30 and 55 years of age (Part 2), inclusive.
• A body mass index of between 18.0 and 32.0 kg/m2, inclusive.
• Contraception requirements for male & female subjects.

Exclusion Criteria:

• Known hypersensitivity or allergy to AMT-126 or excipient contained in the drug formulation.
• Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).
• Presence, or history of clinically significant disease which requires treatment, as judged by the investigator.
• Evidence of current SARS-CoV-2 or COVID infection.
• Women of child-bearing potential.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMT-126; oral AMT-126	Drug: AMT-126; Single or daily dosing at doses A, B, C, D, E, F; G, H, and I; Other Names: no other name applicable
Placebo Comparator: Placebo; oral placebo	Drug: Placebo; Single or daily dosing at doses A, B, C, D, E, F; G,H, and I; Other Names: no other name applicable
Other: Radioactive Tablet (Part 2 only); oral radioactive tablet for scintigraphic analysis	Other: Radioactive Tablet (Part 2 Only); Single dose in two periods in Part 2 (optional); Other Names: no other name applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-emergent adverse events (safety and tolerability)	Single ascending doses of AMT-126 in healthy adult volunteers by evaluation of incidence of treatment-related adverse events as assessed by CTCAE v5.0	5 days
To assess the in vivo performance of an AMT-126 tablet formulation (Optional, Part 2 only)	Qualitative scintigraphic data will be compiled using the following data points for analysis: tablet release (hh:mm), location of tablet release (anatomical location), gastric emptying and arrival times (hh:mm)	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess pharmacokinetics of AMT-126 in healthy volunteers	Assess PK parameters (i.e. Cmax) as applicable for AMT-126	5 days

Collaborators and Investigators

• Sponsor: Applied Molecular Transport

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Actual): March 26, 2022
• Study Completion (Actual): March 26, 2022

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: AMT-126-001; 2020-005779-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No