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

Atrogi

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: ATR-258

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05409924

ATR-258-study-1

Details and patient eligibility

About

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

Enrollment: 71 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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71 participants in 3 patient groups

Phase A

Experimental group

Description:

ATR-258 Single Ascending Dose or placebo

Treatment:

Drug: ATR-258

Drug: ATR-258

Drug: ATR-258

Phase B

Experimental group

Description:

ATR-258 Multiple Ascending Dose or placebo

Treatment:

Drug: ATR-258

Drug: ATR-258

Drug: ATR-258

Phase C

Experimental group

Description:

ATR-258 Repeated dosing or placebo

Treatment:

Drug: ATR-258

Drug: ATR-258

Drug: ATR-258