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ALN-PNP for Healthy Subjects

Recruiting at 5 trial locations

Overseen ByClinical Trials Administrator

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Regeneron Pharmaceuticals

Disqualifiers: Chronic liver disease, Type 1 diabetes, others

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called ALN-PNP on healthy people and those with a specific liver condition (NAFLD) and gene variant. The goal is to see if the drug is safe, tolerable, and effective in reducing liver fat. Researchers are also studying how the body processes the drug.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

How is the drug ALN-PNP different from other treatments?

ALN-PNP is unique because it uses an active placebo control, which mimics the side effects of the actual drug to prevent participants from knowing if they are receiving the real treatment or a placebo, enhancing the reliability of the trial results.¹ ² ³ ⁴ ⁵

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

For Japanese cohorts ONLY; the Japanese participant must:

Be Japanese, born in Japan, and have both biologic parents and 4 biologic grandparents who are ethnically Japanese and born in Japan

Have maintained a Japanese lifestyle, with no significant change since leaving Japan, including having access to Japanese food and adhering to a Japanese diet

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Exclusion Criteria

History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological, or dermatologic 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

Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study

Hospitalized for any reason within 30 days of the screening visit

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of ALN-PNP or placebo to assess safety, tolerability, and pharmacokinetics

Up to 36 weeks

Multiple visits for blood sampling and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 36 weeks

Optional Extension

Optional cohort for additional dose characterization of ALN-PNP

Treatment Details

Interventions

ALN-PNP (RNAi Therapeutics)
Placebo (Other)

Trial OverviewThe 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.

Participant Groups

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