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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Active

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

ATR-258

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

CRS Clinical Research Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Phase A

Phase B

Phase C

Arm Description

ATR-258 Single Ascending Dose or placebo

ATR-258 Multiple Ascending Dose or placebo

ATR-258 Repeated dosing or placebo

Outcomes

Primary Outcome Measures

Safety analyses after single dose of ATR-258

Safety analyses will be performed based in incidence of TEAEs after single dose of ATR-258

Safety analyses after multiple doses of ATR-258

Safety analyses will be performed based in incidence of TEAEs after multiple doses of ATR-258

Secondary Outcome Measures

PK analyses will be performed after PK of ATR-258 single dose

PK analyses will be performed based on AUC0-inf of ATR-258 in plasma

PK analyses will be performed after PK of ATR-258 single dose

PK analyses will be performed based on AUC0-tz of ATR-258 in plasma

PK analyses will be performed after PK of ATR-258 single dose

PK analyses will be performed based on Cmax of ATR-258 in plasma

PK analyses will be performed after PK of ATR-258 multiple dose

PK analyses will be performed based on AUCtau of ATR-258 in plasma

PK analyses will be performed after PK of ATR-258 multiple dose

PK analyses will be performed based on AUC0-tz,MD of ATR-258 in plasma

PK analyses will be performed after PK of ATR-258 multiple dose

PK analyses will be performed based on Cmax,MD of ATR-258 in plasma

Full Information

NCT ID

NCT05409924

First Posted

May 13, 2022

Last Updated

August 18, 2023

Sponsor

Atrogi AB

Collaborators

Key2Compliance, CRS Clinical Research Services

1. Study Identification

Unique Protocol Identification Number

NCT05409924

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 11, 2022 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Atrogi AB

Collaborators

Key2Compliance, CRS Clinical Research Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Phase A

Arm Type

Experimental

Arm Description

ATR-258 Single Ascending Dose or placebo

Arm Title

Phase B

Arm Type

Experimental

Arm Description

ATR-258 Multiple Ascending Dose or placebo

Arm Title

Phase C

Arm Type

Experimental

Arm Description

ATR-258 Repeated dosing or placebo

Intervention Type

Drug

Intervention Name(s)

ATR-258

Other Intervention Name(s)

Placebo

Intervention Description

Single Ascending Dose

Intervention Type

Drug

Intervention Name(s)

ATR-258

Other Intervention Name(s)

Placebo

Intervention Description

Multiple Ascending Dose

Intervention Type

Drug

Intervention Name(s)

ATR-258

Other Intervention Name(s)

Placebo

Intervention Description

Repeat Dose

Primary Outcome Measure Information:

Title

Safety analyses after single dose of ATR-258

Description

Safety analyses will be performed based in incidence of TEAEs after single dose of ATR-258

Time Frame

maximum 7 days post dosing

Title

Safety analyses after multiple doses of ATR-258

Description

Safety analyses will be performed based in incidence of TEAEs after multiple doses of ATR-258

Time Frame

maximum 56 days post dosing

Secondary Outcome Measure Information:

Title

PK analyses will be performed after PK of ATR-258 single dose

Description

PK analyses will be performed based on AUC0-inf of ATR-258 in plasma

Time Frame

maximum 7 days post dosing

Title

PK analyses will be performed after PK of ATR-258 single dose

Description

PK analyses will be performed based on AUC0-tz of ATR-258 in plasma

Time Frame

maximum 7 days post dosing

Title

PK analyses will be performed after PK of ATR-258 single dose

Description

PK analyses will be performed based on Cmax of ATR-258 in plasma

Time Frame

maximum 7 days post dosing

Title

PK analyses will be performed after PK of ATR-258 multiple dose

Description

PK analyses will be performed based on AUCtau of ATR-258 in plasma

Time Frame

maximum 56 days post dosing

Title

PK analyses will be performed after PK of ATR-258 multiple dose

Description

PK analyses will be performed based on AUC0-tz,MD of ATR-258 in plasma

Time Frame

maximum 56 days post dosing

Title

PK analyses will be performed after PK of ATR-258 multiple dose

Description

PK analyses will be performed based on Cmax,MD of ATR-258 in plasma

Time Frame

maximum 56 days post dosing

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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 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

Facility Information:

Facility Name

CRS Clinical Research Services

City

Mannheim

Country

Germany

12. IPD Sharing Statement

Links:

URL

https://atrogi.com/

Description

Related Info

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

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