Status:
COMPLETED
First-in-human Single and Multiple Dose Trial of ATR-258
Lead Sponsor:
Atrogi AB
Collaborating Sponsors:
Key2Compliance
CRS Clinical Research Services Mannheim GmbH
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This is a single-site, randomized, double-blinded, placebo-controlled, First-in-Human trial, conducted in 3 parts.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2023
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT05409924
Start Date
April 11 2022
End Date
October 4 2023
Last Update
December 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CRS Clinical Research Services
Mannheim, Germany