[Translation] A randomized, double-blind, placebo-controlled, single-ascending dose Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of DNV001 injection in subjects with normal or elevated low-density lipoprotein cholesterol

主要目的： 1. 评价受试者单次DNV001注射液皮下给药后的安全性、耐受性。次要目的： 2. 评价受试者单次DNV001注射液皮下给药后的药代动力学（PK）特征； 3. 评价受试者单次DNV001注射液皮下给药后对血清LDL-C水平的药效学影响； 4. 评价受试者单次DNV001注射液皮下给药后对血浆PCSK9水平的药效学影响； 5. 评价受试者单次DNV001注射液皮下给药后对血清其他血脂参数的药效学影响； 6. 评价受试者单次DNV001注射液皮下给药后的免疫原性。探索性目的： 7. 受试者单次DNV001注射液皮下给药对QT间期的影响。

[Translation]

Main objectives: 1. To evaluate the safety and tolerability of a single subcutaneous administration of DNV001 injection to subjects. Secondary objectives: 2. To evaluate the pharmacokinetic (PK) characteristics of a single subcutaneous administration of DNV001 injection to subjects; 3. To evaluate the pharmacodynamic effect of a single subcutaneous administration of DNV001 injection on serum LDL-C levels; 4. To evaluate the pharmacodynamic effect of a single subcutaneous administration of DNV001 injection on plasma PCSK9 levels; 5. To evaluate the pharmacodynamic effect of a single subcutaneous administration of DNV001 injection on other serum lipid parameters; 6. To evaluate the immunogenicity of a single subcutaneous administration of DNV001 injection to subjects. Exploratory objectives: 7. The effect of a single subcutaneous administration of DNV001 injection on the QT interval of subjects.

Start Date21 Apr 2025

Sponsor / Collaborator

Hangzhou Dingle Xinwei Biotechnology Co., Ltd.

100 Clinical Results associated with DNV001

100 Translational Medicine associated with DNV001

100 Patents (Medical) associated with DNV001

Literatures (Medical) associated with DNV001

01 Jan 1998·Genes & Genetic SystemsQ4 · BIOLOGY

Genetic- mapping of RAPD markers linked to the densonucleosis refractoriness gene, nsd-1, in the silkworm, Bombyx mori.

Q4 · BIOLOGY

Article

Author: Abe, Hiroaki ; Harada, Tae ; Shimada, Toru ; Oshiki, Toshikazu ; Kanehara, Mariko ; Ohbayashi, Fumi

In the silkworm, Bombyx mori, nonsusceptibility to B. mori densonucleosis virus type-1 (BmDNV-1) is controlled by a recessive gene, nsd-1 (nonsusceptibility to DNV-1), located on the twenty-first chromosome. We investigated genetic linkage between five random amplified polymorphic DNA (RAPD) markers and the +nsd-1 gene. Initially, we constructed the CSD-1 strain (nsd-1/+) which is congenic to strain C137 (nsd-1/nsd-1) for the twenty-first chromosome, starting with a female of C137 and a male of strain J137 (+nsd-1/+nsd-1). For the crossing over experiment, a female of C137 was crossed with a male (nsd-1/+) of CSD-1. Segregation analysis showed that the most closely linked RAPD marker mapped 3.0 cM distant from +nsd-1. A more specific marker for +nsd-1 was made by converting this RAPD band into a sequence characterized amplified region (SCAR) using a series of newly designed primer pairs based on its DNA sequence.

01 Sep 1994·Archives of VirologyQ4 · MEDICINE

A densovirus newly isolated from the smoky-brown cockroachPeriplaneta fuliginosa

Q4 · MEDICINE

Article

Author: H Bando ; Y Hu ; J Zheng ; T Iizuka

We purified a causing agent of fetal disease for smoky-brown cockroach Periplaneta fuliginosa, which was designated as "cockroach small spherical virus (CSSV)". Purified virus particles had a diameter of 22 +/- 0.6 nm and contained DNA as a single-stranded form. However, the extraction of DNA under condition of appropriate high salt and elevated temperature yielded a double-stranded DNA with a size of 5,500 nucleotides. These results were quite similar to those of other densoviruses (DNVs). The CSSV had five structural proteins (VP1: 52 KDa, VP2: 56 KDa, VP3: 79 KDa, VP4: 82 KDa, and VP5: 105 KDa). The SDS-PAGE profile of these proteins was quite different from that of the cockroach DNV previously reported and was rather similar to that of Bombyx mori (Bm) DNV-1. An immunochemical study, however, demonstrated that there was no immunological relationship between the CSSV and the Bm DNV-1. These data suggest that the CSSV is a new member of DNV.

100 Deals associated with DNV001

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Indication	Highest Phase	Country/Location	Organization	Date
Hyper LDL cholesterolaemia	Phase 1	China	Hangzhou Dingle Xinwei Biotechnology Co., Ltd.	21 Apr 2025
Complex dyslipidemia	IND Approval	China	Hangzhou Dingle Xinwei Biotechnology Co., Ltd.	11 Apr 2025
Primary hypercholesterolemia	IND Approval	China	Hangzhou Dingle Xinwei Biotechnology Co., Ltd.	11 Apr 2025

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