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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04561245




Registration number
NCT04561245
Ethics application status
Date submitted
16/09/2020
Date registered
23/09/2020
Date last updated
10/11/2021

Titles & IDs
Public title
ALT-801 in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of ALT-801 in Healthy Overweight and Obese Volunteers
Secondary ID [1] 0 0
ALT-801-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NASH - Nonalcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALT-801
Other interventions - Placebo

Experimental: ALT-801 (Part 1) - Escalating doses of ALT-801 administered once

Placebo Comparator: Placebo (Part 1) - Placebo administered once

Experimental: ALT-801 (Part 2) - Escalating doses of ALT-801 administered once weekly for 12 weeks

Placebo Comparator: Placebo (Part 2) - Placebo administered once weekly for 12 weeks


Treatment: Drugs: ALT-801
Injected subcutaneously (SC)

Other interventions: Placebo
Injected subcutaneously (SC)
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Part 1 SAD Cohorts: up to Day 26; Part 2 MAD Cohorts: up to Day 42
Primary outcome [2] 0 0
Pharmacokinetic (PK): Maximum observed concentration (Cmax) of ALT-801
Timepoint [2] 0 0
Baseline, Day 26
Primary outcome [3] 0 0
Pharmacokinetic (PK): Area Under the Concentration (AUC) vs Time Curve of ALT-801
Timepoint [3] 0 0
Baseline to Day 26
Primary outcome [4] 0 0
Change in body weight
Timepoint [4] 0 0
Baseline to Week 6
Primary outcome [5] 0 0
Pharmacodynamic (PD): Change from baseline in magnetic resonance derived proton density fat fraction (MRI-PDFF)
Timepoint [5] 0 0
Baseline to Week 6

Eligibility
Key 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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/10/2021
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Nucleus Networks - Herston
Recruitment postcode(s) [1] 0 0
- Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Altimmune, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04561245
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries