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

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Atrogi AB
• Collaborators: CRS Clinical Research Services; Key2Compliance

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 40 to 65 years of age inclusive, at the time of signing the informed consent.

• BMI within the range 25.0 to 40.0 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