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NCT03241264

A Study of Safety, Tolerability, and the Effects Two ND-L02-s0201 Have on the Body

Completed Phase 1 Last updated 7 August 2017
What this trial tests

Phase 1 trial testing ND-L02-s0201 in Fibrosis in 12 participants. Completed in 21 October 2016.

Timeline
28 August 2016
Primary endpoint
21 October 2016
21 October 2016

Quick facts

Lead sponsorBristol-Myers Squibb
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposebasic science
Enrollment12
Start date28 August 2016
Primary completion21 October 2016
Estimated completion21 October 2016

Drugs / interventions tested

Conditions studied

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

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

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability, and the effects two ND-L02-s0201 have on the body

Publications & conference data

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

  1. Therapeutic siRNA: state of the art.
    Hu B, Zhong L, Weng Y, Peng L, et al · · 2020 · cited 991× · PMID 32561705 · DOI 10.1038/s41392-020-0207-x
  2. Nanoparticles in the clinic: An update.
    Anselmo AC, Mitragotri S. · · 2019 · cited 976× · PMID 31572799 · DOI 10.1002/btm2.10143
  3. Passive, active and endogenous organ-targeted lipid and polymer nanoparticles for delivery of genetic drugs.
    Dilliard SA, Siegwart DJ. · · 2023 · cited 384× · PMID 36691401 · DOI 10.1038/s41578-022-00529-7
  4. Nanoparticles in the clinic: An update post COVID-19 vaccines.
    Anselmo AC, Mitragotri S. · · 2021 · cited 211× · PMID 34514159 · DOI 10.1002/btm2.10246
  5. The landscape of nanoparticle-based siRNA delivery and therapeutic development.
    Moazzam M, Zhang M, Hussain A, Yu X, et al · · 2024 · cited 116× · PMID 38204162 · DOI 10.1016/j.ymthe.2024.01.005
  6. Lipid Delivery Systems for Nucleic-Acid-Based-Drugs: From Production to Clinical Applications.
    Barba AA, Bochicchio S, Dalmoro A, Lamberti G. · · 2019 · cited 76× · PMID 31344836 · DOI 10.3390/pharmaceutics11080360
  7. Modification of Lipid-Based Nanoparticles: An Efficient Delivery System for Nucleic Acid-Based Immunotherapy.
    Zhang C, Ma Y, Zhang J, Kuo JC, et al · · 2022 · cited 57× · PMID 35335310 · DOI 10.3390/molecules27061943
  8. Therapeutic potential for renal fibrosis by targeting Smad3-dependent noncoding RNAs.
    Gu YY, Liu XS, Lan HY. · · 2024 · cited 25× · PMID 38093516 · DOI 10.1016/j.ymthe.2023.12.009

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Other recruiting trials for Fibrosis

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Data sources for this page

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