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

• Status: Completed
• Trial end date: 2021-10-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Altimmune, Inc.

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:

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