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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06452771




Registration number
NCT06452771
Ethics application status
Date submitted
5/06/2024
Date registered
11/06/2024

Titles & IDs
Public title
A First In Human (FIH) Study to Learn if Different Doses of ALN-ANG3 Are Safe and Well Tolerated in Healthy Adults
Scientific title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Pharmacokinetics of ALN-ANG3 in Otherwise Healthy Adult Participants
Secondary ID [1] 0 0
ALN-ANG3-HV-2348
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALN-ANG3
Treatment: Drugs - Placebo (PB)

Experimental: Ascending Dose - Multiple Dose Level (DL) Cohorts, with 1 Optional DL or Repeat DL

Experimental: Optional Expansion - Multiple Optional Expansion Cohorts, activation will be determined by the Sponsor


Treatment: Drugs: ALN-ANG3
Administered subcutaneous (SC) injection

Treatment: Drugs: Placebo (PB)
Administered SC injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Up to Approximately 239 Days
Primary outcome [2] 0 0
Severity of TEAEs
Timepoint [2] 0 0
Up to Approximately 239 Days
Secondary outcome [1] 0 0
Concentration of ALN-ANG3 in plasma
Timepoint [1] 0 0
Within 3 Days Postdose
Secondary outcome [2] 0 0
Concentration of ALN-ANG3 metabolite(s) in plasma
Timepoint [2] 0 0
Within 3 Days Postdose
Secondary outcome [3] 0 0
Incidence of antidrug antibodies (ADAs) to ALN-ANG3
Timepoint [3] 0 0
Up to Approximately 239 Days
Secondary outcome [4] 0 0
Titer of ADAs to ALN-ANG3
Timepoint [4] 0 0
Up to Approximately 239 Days

Eligibility
Key inclusion criteria
Key

1. Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram's (ECG's) performed at screening and/or prior to administration of initial dose of study drug
2. Has fasting triglyceride (TG) levels >=100 and <500 mg/dL (1.13-5.65 mmol/L) and fasting low-density lipoprotein (LDL-C) >=70 and <=300 mg/dL (1.81-7.76 mmol/L) during screening visits. Testing may be repeated once during the screening period.
3. Has a body mass index between 18 and 35 kg/m^2, inclusive, at screening visit

Key
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological or other disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation
2. Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit
3. Any malignancy, except for non-melanoma skin cancer or cervical/anus in-situ that have been resected with no evidence of metastatic disease for 3 years prior to the screening visit
4. Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food
5. With the exception of stable (approximately 6 months at same dose level) statin use, any prescription medication for approximately 2 weeks or 5 half-lives, whichever is longer, prior to first administration of the study drug through the end of study (EOS). Non-prescription medications and nutritional supplements are permitted after alignment of investigator and sponsor on their use
6. Using the Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology (CKD-ePI) equation, has an estimated Glomerular Filtration Rate (GFR) of <60 mL/min/1.73m2 at the screening visit, as defined in the protocol
7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) with clinically significant abnormality in the opinion of investigator or =1.5× upper limit of normal (ULN) range at screening or day -1 visits
8. Is positive for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg) at the screening visit. Evidence of prior hepatitis B immunization or prior resolved hepatitis B infection is not an exclusion
9. Is positive for hepatitis C antibody and positive for qualitative (ie, detected or not detected) hepatitis C virus (HCV) ribonucleic acid (RNA) test at the screening visit

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

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

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2025
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Administrator
Address 0 0
Country 0 0
Phone 0 0
844-734-6643
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Available to whom?
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06452771