A First In Human (FIH) Study to Learn if Different Doses of ALN-ANG3 Are Safe and Well Tolerated in Healthy Adults

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Pharmacokinetics of ALN-ANG3 in Otherwise Healthy Adult Participants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452771
• Other study ID #: ALN-ANG3-HV-2348
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 28, 2024
• Est. completion date: November 2, 2025

Study information

• Verified date: June 2024
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is researching an experimental drug called ALN-ANG3 (called "study drug"). The study is focused on healthy participants. The aim of the study is to see how safe and tolerable the study drug is in healthy adults. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: November 2, 2025
• Est. primary completion date: November 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

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 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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ALN-ANG3
Administered subcutaneous (SC) injection
• Placebo (PB)
Administered SC injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs)	In participants treated with ALN-ANG3 or placebo (PBO)	Up to Approximately 239 Days
Primary	Severity of TEAEs	In participants treated with ALN-ANG3 or PBO	Up to Approximately 239 Days
Secondary	Concentration of ALN-ANG3 in plasma		Within 3 Days Postdose
Secondary	Concentration of ALN-ANG3 metabolite(s) in plasma		Within 3 Days Postdose
Secondary	Incidence of antidrug antibodies (ADAs) to ALN-ANG3		Up to Approximately 239 Days
Secondary	Titer of ADAs to ALN-ANG3		Up to Approximately 239 Days