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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05476107

Enrollment

Registered

2022-07-27

Start date

2021-02-26

Completion date

2022-03-26

Last updated

2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief 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

Interventions

DRUGAMT-126

Single or daily dosing at doses A, B, C, D, E, F; G, H, and I

DRUGPlacebo

Single or daily dosing at doses A, B, C, D, E, F; G,H, and I

OTHERRadioactive Tablet (Part 2 Only)

Single dose in two periods in Part 2 (optional)

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

Double-blinded (Part 1), Open Label (Part 2)

Intervention model description

Study participants will be randomized to either receive AMT-126 or placebo (Part 1), Radiolabeled tablet (Part 2)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment-emergent adverse events (safety and tolerability)	5 days	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
To assess the in vivo performance of an AMT-126 tablet formulation (Optional, Part 2 only)	5 days	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)

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026