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RNAi Therapeutics

ALN-PNP for Healthy Subjects

Verified Trial
Phase 1
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 253
Awards & highlights

Study Summary

This trial will test a drug's safety and how it works in healthy adults. It will also look at how the body responds to it and its effect on cholesterol levels.

Who is the study for?
This trial is for healthy adults, including specific criteria for Japanese participants such as being born in Japan with Japanese parents and grandparents, living a Japanese lifestyle, and not having lived outside of Japan for more than 10 years. Participants must have a BMI between 18-32 and be in good health based on lab tests. Smokers or recent smokers, those with significant diseases or abnormal lab results are excluded.Check my eligibility
What is being tested?
The study is testing the safety and how well people tolerate ALN-PNP when given once to healthy adults compared to a placebo. It will also look at how the body processes ALN-PNP, its effects on immune response, and any changes it might cause in blood lipid levels.See study design
What are the potential side effects?
Since this is an early-stage trial to determine safety and tolerability, potential side effects are not fully known yet but may include typical drug-related reactions like injection site discomfort, allergic reactions, fatigue or changes in blood test results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 253
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 253 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of TEAEs by severity
Incidence of treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Change in apolipoprotein A1 (ApoA1) over time
Change in apolipoprotein B (ApoB) over time
Change in high-density lipoprotein (HDL) over time
+9 more

Trial Design

12Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: ALN-PNP Dose 5Experimental Treatment1 Intervention
Up to 32 Participants Randomized 1:1:1:1 resulting in 8 participants per arm
Group II: Part B: ALN-PNP Dose 4Experimental Treatment1 Intervention
Up to 32 Participants Randomized 1:1:1:1 resulting in 8 participants per arm
Group III: Part B: ALN-PNP Dose 3Experimental Treatment1 Intervention
Up to 32 Participants Randomized 1:1:1:1 resulting in 8 participants per arm
Group IV: Part A: Optional ALN-PNP Dose 5 or PBExperimental Treatment2 Interventions
8 Participants, Randomized 6:2 This is an optional cohort, if there is a need for additional dose characterization of ALN-PNP.
Group V: Part A: JPN ALN-PNP Dose 5 or PBExperimental Treatment2 Interventions
8 Japanese Participants only, Randomized 6:2
Group VI: Part A: JPN ALN-PNP Dose 4 or PBExperimental Treatment2 Interventions
8 Japanese Participants only, Randomized 6:2
Group VII: Part A: ALN-PNP Dose 5 or PBExperimental Treatment2 Interventions
8 Participants, Randomized 6:2
Group VIII: Part A: ALN-PNP Dose 4 or PBExperimental Treatment2 Interventions
8 Participants, Randomized 6:2
Group IX: Part A: ALN-PNP Dose 3 or PBExperimental Treatment2 Interventions
8 Participants, Randomized 6:2
Group X: Part A: ALN-PNP Dose 2 or PBExperimental Treatment2 Interventions
8 Participants, Randomized 6:2
Group XI: Part A: ALN-PNP Dose 1 or PBExperimental Treatment2 Interventions
8 Participants, Randomized 6:2
Group XII: Part B: PlaceboPlacebo Group1 Intervention
Up to 32 Participants Randomized 1:1:1:1 resulting in 8 participants per arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo (PB)
2004
Completed Phase 2
~90

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
620 Previous Clinical Trials
380,369 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
5,535 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
262 Previous Clinical Trials
251,178 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
5,535 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

ALN-PNP (RNAi Therapeutics) Clinical Trial Eligibility Overview. Trial Name: NCT05648214 — Phase 1
Non-alcoholic Fatty Liver Disease Research Study Groups: Part A: ALN-PNP Dose 3 or PB, Part A: JPN ALN-PNP Dose 4 or PB, Part B: Placebo, Part A: ALN-PNP Dose 2 or PB, Part A: ALN-PNP Dose 4 or PB, Part A: ALN-PNP Dose 5 or PB, Part A: Optional ALN-PNP Dose 5 or PB, Part A: JPN ALN-PNP Dose 5 or PB, Part B: ALN-PNP Dose 3, Part B: ALN-PNP Dose 4, Part B: ALN-PNP Dose 5, Part A: ALN-PNP Dose 1 or PB
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: ALN-PNP Highlights & Side Effects. Trial Name: NCT05648214 — Phase 1
ALN-PNP (RNAi Therapeutics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05648214 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are participating in this research endeavor?

"Affirmative. Clinicaltrials.gov showcases that this medical experiment, which was published on December 27th 2022 and last revised on January 31st 2023, is actively recruiting participants. 64 individuals need to be enrolled from a single trial site."

Answered by AI

Are individuals over thirty years old eligible for this trial?

"According to the criteria, this trial is most suitable for individuals aged 18-55. Nonetheless, there are 50 trials available for minors and 353 studies accessible to seniors over 65."

Answered by AI

Has the administration granted authorization for ALN-PNP Dose 1 or PB?

"The safety of ALN-PNP Dose 1 or PB is rated a 1 on our Power team's scale due to the fact that this clinical trial is in its initial phase, so there exists only minimal evidence attesting to its efficacy and security."

Answered by AI

Which individuals may partake in this experiment?

"This study mandates that prospective participants must be between the ages of 18 and 55, with a healthy medical background. Interested parties should note that 64 people are needed for this research project."

Answered by AI

Is enrollment for this experiment still open?

"Affirmative. Clinicaltrials.gov's dataset indicates that this medical experiment is presently enrolling volunteers; the initial posting was on December 27th 2022 and the latest edit occurred on January 31st 2023. This research requires 64 patients to be recruited from 1 site."

Answered by AI

Who else is applying?

What site did they apply to?
Tandem Clinical Research, Marrero
California Clinical Trials Medical Group
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Most responsive sites:
  1. Tandem Clinical Research, Marrero: < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Non-Alcoholic Fatty Liver Disease (NAFLD)
2022. "A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Non-Alcoholic Fatty Liver Disease (NAFLD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05648214.
All > Nafld
~48 spots leftby Sep 2025
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