First-in-human Single and Multiple Dose Trial of ATR-258

Study Overview
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Brief Summary
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This is a single-site, randomized, double-blinded, placebo-controlled, First-in-Human trial, conducted in 3 parts.

Official Title
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The ATTRACTIVE 1 Trial - a First-in-human Phase I, Dose Escalating, Double-blind, Placebo-controlled, Single and Multiple Dose Trial of ATR-258 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: ATR-258
* Drug: ATR-258
* Drug: ATR-258


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Phase A and B: Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. Body mass index (BMI) within the range 18.5 - 29.9 kg/m2 (inclusive) at screening. Male Inclusion Criteria Phase C: Participant must be 30 to 75 years of age inclusive, at the time of signing the informed consent. BMI within the range 25.0 to 45.0 kg/m2 and body weight from 80 to 160 kg (inclusive) at screening. Male Exclusion Criteria Phase C: Type 1 diabetes mellitus (T1DM) or ketosis-prone T2D based on diagnosis

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

Sexes Eligible for Study
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Male

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase A<br>ATR-258 Single Ascending Dose or placebo | Drug: ATR-258<br>* Single Ascending Dose<br>* Other names: Placebo;|
| Experimental: Phase B<br>ATR-258 Multiple Ascending Dose or placebo | Drug: ATR-258<br>* Multiple Ascending Dose<br>* Other names: Placebo;|
| Experimental: Phase C<br>ATR-258 Repeated dosing or placebo | Drug: ATR-258<br>* Repeat Dose<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety analyses after single dose of ATR-258 | Safety analyses will be performed based in incidence of TEAEs after single dose of ATR-258 | maximum 7 days post dosing | 
| Safety analyses after multiple doses of ATR-258 | Safety analyses will be performed based in incidence of TEAEs after multiple doses of ATR-258 | maximum 56 days post dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK analyses will be performed after PK of ATR-258 single dose | PK analyses will be performed based on AUC0-inf of ATR-258 in plasma | maximum 7 days post dosing | 
| PK analyses will be performed after PK of ATR-258 single dose | PK analyses will be performed based on AUC0-tz of ATR-258 in plasma | maximum 7 days post dosing | 
| PK analyses will be performed after PK of ATR-258 single dose | PK analyses will be performed based on Cmax of ATR-258 in plasma | maximum 7 days post dosing | 
| PK analyses will be performed after PK of ATR-258 multiple dose | PK analyses will be performed based on AUCtau of ATR-258 in plasma | maximum 56 days post dosing | 
| PK analyses will be performed after PK of ATR-258 multiple dose | PK analyses will be performed based on AUC0-tz,MD of ATR-258 in plasma | maximum 56 days post dosing | 
| PK analyses will be performed after PK of ATR-258 multiple dose | PK analyses will be performed based on Cmax,MD of ATR-258 in plasma | maximum 56 days post dosing |