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ALT-801 in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

ALT-801

Placebo

About this trial

This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis focused on measuring NASH, Nonalcoholic Steatohepatitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male or female healthy volunteers, age 18 to 60 years, inclusive
Overweight to obese (BMI 25.0 - 40.0 kg/m2)
MRI-PDFF≥ 10% (Part 2 only)
Subjects must otherwise be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study medication
Ability and willingness to attend the necessary visits to the study center
Written informed consent signed prior to entry into the study

Exclusion Criteria:

Women who are pregnant or breastfeeding
History of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or HbA1c ≥ 6.5%
History of neoplastic disease, or personal or family history of multiple endocrine neoplasia or medullary cancer of the thyroid, with the following exceptions:
1. Adequately treated non-melanomatous skin carcinoma
2. Female with a history of benign cervical neoplasia if the subject has been compliant with surveillance and treatment as recommended by her physician
Mentally or legally incapacitated, has significant emotional problems at the time of screening or expected during the conduct of the study
Clinically significant laboratory abnormalities including:
a. Impaired renal function
Unlikely to comply with the study protocol or, in the opinion of the Investigator, would not be a suitable candidate for participation in the study

Sites / Locations

Nucleus Networks

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

ALT-801 (Part 1)

Placebo (Part 1)

ALT-801 (Part 2)

Placebo (Part 2)

Arm Description

Escalating doses of ALT-801 administered once

Placebo administered once

Escalating doses of ALT-801 administered once weekly for 12 weeks

Placebo administered once weekly for 12 weeks

Outcomes

Primary Outcome Measures

The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)

Pharmacokinetic (PK): Maximum observed concentration (Cmax) of ALT-801

Pharmacokinetic (PK): Area Under the Concentration (AUC) vs Time Curve of ALT-801

Change in body weight

Pharmacodynamic (PD): Change from baseline in magnetic resonance derived proton density fat fraction (MRI-PDFF)

Secondary Outcome Measures

Full Information

NCT ID

NCT04561245

First Posted

September 16, 2020

Last Updated

November 8, 2021

Sponsor

Altimmune, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04561245

Brief Title

ALT-801 in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of ALT-801 in Healthy Overweight and Obese Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

November 10, 2020 (Actual)

Primary Completion Date

October 23, 2021 (Actual)

Study Completion Date

October 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Altimmune, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of the study is to assess the safety and tolerability in healthy overweight and obese volunteers administered single or multiple repeated doses of ALT-801. This study has 2 parts. Part 1 involves a single dose of ALT-801 taken as a subcutaneous (SC) injection and will be approximately 36 days in duration. Part 2 involves 12 doses of ALT-801, once a week for 12 weeks, as a SC injection and will be approximately 116 days in duration. Each participant will enroll in only one part.

6. Conditions and Keywords

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

NASH - Nonalcoholic Steatohepatitis

Keywords

NASH, Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALT-801 (Part 1)

Arm Type

Experimental

Arm Description

Escalating doses of ALT-801 administered once

Arm Title

Placebo (Part 1)

Arm Type

Placebo Comparator

Arm Description

Placebo administered once

Arm Title

ALT-801 (Part 2)

Arm Type

Experimental

Arm Description

Escalating doses of ALT-801 administered once weekly for 12 weeks

Arm Title

Placebo (Part 2)

Arm Type

Placebo Comparator

Arm Description

Placebo administered once weekly for 12 weeks

Intervention Type

Drug

Intervention Name(s)

ALT-801

Intervention Description

Injected subcutaneously (SC)

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Injected subcutaneously (SC)

Primary Outcome Measure Information:

Title

The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)

Time Frame

Part 1 SAD Cohorts: up to Day 26; Part 2 MAD Cohorts: up to Day 42

Title

Pharmacokinetic (PK): Maximum observed concentration (Cmax) of ALT-801

Time Frame

Baseline, Day 26

Title

Pharmacokinetic (PK): Area Under the Concentration (AUC) vs Time Curve of ALT-801

Time Frame

Baseline to Day 26

Title

Change in body weight

Time Frame

Baseline to Week 6

Title

Pharmacodynamic (PD): Change from baseline in magnetic resonance derived proton density fat fraction (MRI-PDFF)

Time Frame

Baseline to Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female healthy volunteers, age 18 to 60 years, inclusive Overweight to obese (BMI 25.0 - 40.0 kg/m2) MRI-PDFF≥ 10% (Part 2 only) Subjects must otherwise be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study medication Ability and willingness to attend the necessary visits to the study center Written informed consent signed prior to entry into the study Exclusion Criteria: Women who are pregnant or breastfeeding History of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or HbA1c ≥ 6.5% History of neoplastic disease, or personal or family history of multiple endocrine neoplasia or medullary cancer of the thyroid, with the following exceptions: Adequately treated non-melanomatous skin carcinoma Female with a history of benign cervical neoplasia if the subject has been compliant with surveillance and treatment as recommended by her physician Mentally or legally incapacitated, has significant emotional problems at the time of screening or expected during the conduct of the study Clinically significant laboratory abnormalities including: a. Impaired renal function Unlikely to comply with the study protocol or, in the opinion of the Investigator, would not be a suitable candidate for participation in the study

Facility Information:

Facility Name

Nucleus Networks

City

Herston

State/Province

Queensland

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

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ALT-801 in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability

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