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

December 15, 2023 updated by: Atrogi AB

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany
        • CRS Clinical Research Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase A
ATR-258 Single Ascending Dose or placebo
Drug: ATR-258
Single Ascending Dose
Other Names:
  • Placebo
Drug: ATR-258
Multiple Ascending Dose
Other Names:
  • Placebo
Drug: ATR-258
Repeat Dose
Other Names:
  • Placebo
Experimental: Phase B
ATR-258 Multiple Ascending Dose or placebo
Drug: ATR-258
Single Ascending Dose
Other Names:
  • Placebo
Drug: ATR-258
Multiple Ascending Dose
Other Names:
  • Placebo
Drug: ATR-258
Repeat Dose
Other Names:
  • Placebo
Experimental: Phase C
ATR-258 Repeated dosing or placebo
Drug: ATR-258
Single Ascending Dose
Other Names:
  • Placebo
Drug: ATR-258
Multiple Ascending Dose
Other Names:
  • Placebo
Drug: ATR-258
Repeat Dose
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
maximum 7 days post dosing
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
maximum 56 days post dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK analyses will be performed after PK of ATR-258 single dose
Time Frame: maximum 7 days post dosing
PK analyses will be performed based on AUC0-inf of ATR-258 in plasma
maximum 7 days post dosing
PK analyses will be performed after PK of ATR-258 single dose
Time Frame: maximum 7 days post dosing
PK analyses will be performed based on AUC0-tz of ATR-258 in plasma
maximum 7 days post dosing
PK analyses will be performed after PK of ATR-258 single dose
Time Frame: maximum 7 days post dosing
PK analyses will be performed based on Cmax of ATR-258 in plasma
maximum 7 days post dosing
PK analyses will be performed after PK of ATR-258 multiple dose
Time Frame: maximum 56 days post dosing
PK analyses will be performed based on AUCtau of ATR-258 in plasma
maximum 56 days post dosing
PK analyses will be performed after PK of ATR-258 multiple dose
Time Frame: maximum 56 days post dosing
PK analyses will be performed based on AUC0-tz,MD of ATR-258 in plasma
maximum 56 days post dosing
PK analyses will be performed after PK of ATR-258 multiple dose
Time Frame: maximum 56 days post dosing
PK analyses will be performed based on Cmax,MD of ATR-258 in plasma
maximum 56 days post dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atrogi AB

Collaborators

Key2Compliance
CRS Clinical Research Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2022

Primary Completion (Actual)

October 4, 2023

Study Completion (Actual)

October 4, 2023

Study Registration Dates

First Submitted

May 13, 2022

First Submitted That Met QC Criteria

June 4, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATR-258-study-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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