ALT-801 in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ALT-801 (Part 1) Escalating doses of ALT-801 administered once |
Drug: ALT-801
Injected subcutaneously (SC)
|
| Placebo Comparator: Placebo (Part 1) Placebo administered once |
Other: Placebo
Injected subcutaneously (SC)
|
| Experimental: ALT-801 (Part 2) Escalating doses of ALT-801 administered once weekly for 12 weeks |
Drug: ALT-801
Injected subcutaneously (SC)
|
| Placebo Comparator: Placebo (Part 2) Placebo administered once weekly for 12 weeks |
Other: Placebo
Injected subcutaneously (SC)
|
Outcome Measures
Primary Outcome Measures
- 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]
- Pharmacokinetic (PK): Maximum observed concentration (Cmax) of ALT-801 [Baseline, Day 26]
- Pharmacokinetic (PK): Area Under the Concentration (AUC) vs Time Curve of ALT-801 [Baseline to Day 26]
- Change in body weight [Baseline to Week 6]
- Pharmacodynamic (PD): Change from baseline in magnetic resonance derived proton density fat fraction (MRI-PDFF) [Baseline to Week 6]
Eligibility Criteria
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:
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nucleus Networks | Herston | Queensland | Australia |
Sponsors and Collaborators
- Altimmune, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALT-801-101