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

NASH - Nonalcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04561245
• Other study ID #: ALT-801-101
• Status: Completed
• Phase: Phase 1
• Start date: November 10, 2020
• Est. completion date: October 23, 2021

Study information

• Verified date: July 2021
• Source: Altimmune, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 23, 2021
• Est. primary completion date: October 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease
• Overweight

Intervention

Drug:
• ALT-801
Injected subcutaneously (SC)

Other:
• Placebo
Injected subcutaneously (SC)

Locations

Country	Name	City	State
Australia	Nucleus Networks	Herston	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Altimmune, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)		Part 1 SAD Cohorts: up to Day 26; Part 2 MAD Cohorts: up to Day 42
Primary	Pharmacokinetic (PK): Maximum observed concentration (Cmax) of ALT-801		Baseline, Day 26
Primary	Pharmacokinetic (PK): Area Under the Concentration (AUC) vs Time Curve of ALT-801		Baseline to Day 26
Primary	Change in body weight		Baseline to Week 6
Primary	Pharmacodynamic (PD): Change from baseline in magnetic resonance derived proton density fat fraction (MRI-PDFF)		Baseline to Week 6