NCT05409924CompletedPhase 1
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Atrogi AB
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Safety analyses after multiple doses of ATR-258
Study Overview
Brief Summary
This is a single-site, randomized, double-blinded, placebo-controlled, First-in-Human trial, conducted in 3 parts.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Phase B
Experimental
ATR-258 Multiple Ascending Dose or placebo
Intervention: ATR-258 (Drug)
Phase A
Experimental
ATR-258 Single Ascending Dose or placebo
Intervention: ATR-258 (Drug)
Phase C
Experimental
ATR-258 Repeated dosing or placebo
Intervention: ATR-258 (Drug)
Outcomes
Primary Outcomes
Safety analyses after multiple doses of ATR-258
Time Frame: maximum 56 days post dosing
Safety analyses will be performed based in incidence of TEAEs after multiple doses of ATR-258
Safety analyses after single dose of ATR-258
Time Frame: maximum 7 days post dosing
Safety analyses will be performed based in incidence of TEAEs after single dose of ATR-258
Secondary Outcomes
- PK analyses will be performed after PK of ATR-258 multiple dose(maximum 56 days post dosing)
- PK analyses will be performed after PK of ATR-258 single dose(maximum 7 days post dosing)
Investigators
Study Sites (1)
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