Clinical trial NCT04561245: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: NASH
Nonalcoholic Steatohepatitis
Lead sponsor: Altimmune, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  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

Primary outcomes:
measure: The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Part 1 SAD Cohorts: up to Day 26; Part 2 MAD Cohorts: up to Day 42
measure: Pharmacokinetic (PK): Maximum observed concentration (Cmax) of ALT-801
timeFrame: Baseline, Day 26
measure: Pharmacokinetic (PK): Area Under the Concentration (AUC) vs Time Curve of ALT-801
timeFrame: Baseline to Day 26
measure: Change in body weight
timeFrame: Baseline to Week 6
measure: Pharmacodynamic (PD): Change from baseline in magnetic resonance derived proton density fat fraction (MRI-PDFF)
timeFrame: Baseline to Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Nucleus Networks
state: Queensland
Study officials:
References: