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

Phase 1CompletedNCT05409924

Atrogi AB71 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

ATR-258DRUG

Single Ascending Dose

ATR-258DRUG

Multiple Ascending Dose

ATR-258DRUG

Repeat Dose

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CRS Clinical Research Services

Mannheim, Germany

Outcomes

Primary Outcomes

Safety analyses after single dose of ATR-258

Safety analyses will be performed based in incidence of TEAEs after single dose of ATR-258

Time frame: 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

Time frame: maximum 56 days post dosing

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: maximum 56 days post dosing

Data from ClinicalTrials.gov

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