First-in-human Single and Multiple Dose Trial of ATR-258
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
1 other identifier
interventional
71
1 country
1
Brief Summary
This is a single-site, randomized, double-blinded, placebo-controlled, First-in-Human trial, conducted in 3 parts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 type-2-diabetes-mellitus
Started Apr 2022
Longer than P75 for phase_1 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2022
CompletedFirst Submitted
Initial submission to the registry
May 13, 2022
CompletedFirst Posted
Study publicly available on registry
June 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2023
CompletedDecember 18, 2023
December 1, 2023
1.5 years
May 13, 2022
December 15, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Safety analyses after single dose of ATR-258
Safety analyses will be performed based in incidence of TEAEs after single dose of ATR-258
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
maximum 56 days post dosing
Secondary Outcomes (6)
PK analyses will be performed after PK of ATR-258 single dose
maximum 7 days post dosing
PK analyses will be performed after PK of ATR-258 single dose
maximum 7 days post dosing
PK analyses will be performed after PK of ATR-258 single dose
maximum 7 days post dosing
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 multiple dose
maximum 56 days post dosing
- +1 more secondary outcomes
Study Arms (3)
Phase A
EXPERIMENTALATR-258 Single Ascending Dose or placebo
Phase B
EXPERIMENTALATR-258 Multiple Ascending Dose or placebo
Phase C
EXPERIMENTALATR-258 Repeated dosing or placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- Type 1 diabetes mellitus (T1DM) or ketosis-prone T2D based on diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atrogi ABlead
- Key2Compliancecollaborator
- CRS Clinical Research Services Mannheim GmbHcollaborator
Study Sites (1)
CRS Clinical Research Services
Mannheim, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2022
First Posted
June 8, 2022
Study Start
April 11, 2022
Primary Completion
October 4, 2023
Study Completion
October 4, 2023
Last Updated
December 18, 2023
Record last verified: 2023-12