NCT04601844 is a Phase 1 clinical trial of Pozelimab in Healthy, sponsored by Regeneron Pharmaceuticals.

Who is sponsoring NCT04601844?

NCT04601844 is sponsored by Regeneron Pharmaceuticals.

What drugs are being tested in NCT04601844?

Interventions in NCT04601844: Pozelimab, Cemdisiran.

Is NCT04601844 still recruiting?

NCT04601844 is currently completed. Last updated 12 November 2021.

Last reviewed 2021-11-12 · How we verify

NCT04601844

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pozelimab in Combination With Cemdisiran in Healthy Adult Volunteers

Completed Phase 1 Last updated 12 November 2021

What this trial tests

Phase 1 trial testing Pozelimab in Healthy in 19 participants. Completed in 23 July 2021.

Timeline

16 November 2020

Primary endpoint
23 July 2021

23 July 2021

Quick facts

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	16 November 2020
Primary completion	23 July 2021
Estimated completion	23 July 2021
Sites	1 location across Belgium

Drugs / interventions tested

Pozelimab (POZELIMAB) — full drug profile →
Cemdisiran — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of the study is to evaluate the safety and tolerability of ascending doses of subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart. The secondary objectives of the study are: * To assess the concentration-time profiles of total pozelimab, total complement component 5 (C5), cemdisiran, and cemdisiran metabolite(s) following single ascending doses of SC pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart * To assess the pharmacodynamic (PD) profile of ascending doses of SC pozelimab and SC cemdisiran, as well as when administered on the same day or sequentially 28 days apart * To assess the immunogenicity of pozelimab and cemdisiran

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Noncoding RNA therapeutics - challenges and potential solutions.
Winkle M, El-Daly SM, Fabbri M, Calin GA. · · 2021 · cited 1123× · PMID 34145432 · DOI 10.1038/s41573-021-00219-z
Non-Coding RNA-Targeted Therapy: A State-of-the-Art Review.
Nappi F. · · 2024 · cited 72× · PMID 38612441 · DOI 10.3390/ijms25073630
RNA therapeutics in the clinic.
Curreri A, Sankholkar D, Mitragotri S, Zhao Z. · · 2023 · cited 62× · PMID 36684099 · DOI 10.1002/btm2.10374
Treatment of Rare Inflammatory Kidney Diseases: Drugs Targeting the Terminal Complement Pathway.
Anliker-Ort M, Dingemanse J, van den Anker J, Kaufmann P. · · 2020 · cited 33× · PMID 33362783 · DOI 10.3389/fimmu.2020.599417
Emerging Role of C5 Complement Pathway in Peripheral Neuropathies: Current Treatments and Future Perspectives.
Giorgio C, Zippoli M, Cocchiaro P, Castelli V, et al · · 2021 · cited 29× · PMID 33917266 · DOI 10.3390/biomedicines9040399
Hepatocyte targeting <i>via</i> the asialoglycoprotein receptor.
Ramírez-Cortés F, Ménová P. · · 2025 · cited 22× · PMID 39628900 · DOI 10.1039/d4md00652f
Gene targeting as a therapeutic avenue in diseases mediated by the complement alternative pathway.
Dreismann AK, Hallam TM, Tam LC, Nguyen CV, et al · · 2023 · cited 22× · PMID 36369963 · DOI 10.1111/imr.13149
Non-coding RNAs: emerging biomarkers and therapeutic targets in cancer and inflammatory diseases.
Hossam Abdelmonem B, Kamal LT, Wardy LW, Ragheb M, et al · · 2025 · cited 19× · PMID 40129920 · DOI 10.3389/fonc.2025.1534862

Verify or expand the search:

Other trials of Pozelimab

Trials testing the same drug.

NCT07154745 — A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hem · Phase 3 · recruiting
NCT07142343 — A Study to Test the Safety of Pozelimab in Pediatric Participants 1 to 5 Years of Age With a Rare Disease Called CHAPLE · Phase 4 · recruiting
NCT07230834 — Intravitreal (IVT) Pozelimab for Geographic Atrophy (GA) in Adult Participants · Phase 1 · recruiting
NCT06541704 — A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult · Phase 3 · recruiting
NCT05744921 — A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With P · Phase 3 · recruiting

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Regeneron Pharmaceuticals trials

Trials by the same sponsor.

NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) · Phase 2, PHASE3 · not yet recruiting
NCT07526116 — A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy Adul · Phase 1 · not yet recruiting
NCT07527923 — First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis · Phase 1 · not yet recruiting
NCT07527910 — A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD · Phase 2 · not yet recruiting
NCT07477704 — A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemi · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04601844 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Regeneron Pharmaceuticals
Last refreshed: 12 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04601844.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing