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

Study Overview
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Brief Summary
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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
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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

Official Title
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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
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Healthy Volunteers

Intervention / Treatment
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* Drug: AMT-126
* Drug: Placebo
* Other: Radioactive Tablet (Part 2 Only)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Study participants will be randomized to either receive AMT-126 or placebo (Part 1), Radiolabeled tablet (Part 2)
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |