Overview

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