Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

247
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
247
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.7K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.7K
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

379
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
379
Preclinical Development: Overview01:28

Preclinical Development: Overview

4.8K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.8K
Clinical Trials01:16

Clinical Trials

8.5K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
8.5K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

In Vivo Base Editing of <i>PCSK9</i> with VERVE-102 for Hypercholesterolemia.

The New England journal of medicine·2026
Same author

ACE-031, a soluble activin type IIB receptor, increases muscle mass and strength in the common marmoset (Callithrix jacchus).

PloS one·2026
Same author

ACE-031, a Soluble Activin Type IIB Receptor, Increases Muscle Mass and Strength in the Common Marmoset (Callithrix jacchus).

bioRxiv : the preprint server for biology·2025
Same author

Lipid residue analysis reveals divergent culinary practices in Japan and Korea at the dawn of intensive agriculture.

Proceedings of the National Academy of Sciences of the United States of America·2025
Same author

Hereditary angioedema plasma proteomics following specific plasma kallikrein inhibition with lanadelumab.

Frontiers in immunology·2025
Same author

Fully Nonlinear Gravitational Wave Simulations from Past to Future Null Infinity.

Physical review letters·2025

Related Experiment Video

Updated: Apr 27, 2026

Author Spotlight: Exploring the Impact of Reduced Resistance Exercise Volume on Metabolic Health
06:13

Author Spotlight: Exploring the Impact of Reduced Resistance Exercise Volume on Metabolic Health

Published on: December 1, 2023

2.1K

A phase 1 study investigating DX-2930 in healthy subjects.

Yung Chyung1, Bradley Vince2, Ryan Iarrobino1

  • 1Dyax Corp, Burlington, Massachusetts.

Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology
|July 2, 2014
PubMed
Summary

DX-2930, a plasma kallikrein inhibitor, was well tolerated in healthy subjects up to 3.0 mg/kg. This study supports its potential for hereditary angioedema prophylaxis.

More Related Videos

Precision Implementation of Minimal Erythema Dose MED Testing to Assess Individual Variation in Human Inflammatory Response
06:31

Precision Implementation of Minimal Erythema Dose MED Testing to Assess Individual Variation in Human Inflammatory Response

Published on: October 3, 2019

8.2K
Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability
08:22

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

Published on: October 7, 2017

9.6K

Related Experiment Videos

Last Updated: Apr 27, 2026

Author Spotlight: Exploring the Impact of Reduced Resistance Exercise Volume on Metabolic Health
06:13

Author Spotlight: Exploring the Impact of Reduced Resistance Exercise Volume on Metabolic Health

Published on: December 1, 2023

2.1K
Precision Implementation of Minimal Erythema Dose MED Testing to Assess Individual Variation in Human Inflammatory Response
06:31

Precision Implementation of Minimal Erythema Dose MED Testing to Assess Individual Variation in Human Inflammatory Response

Published on: October 3, 2019

8.2K
Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability
08:22

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

Published on: October 7, 2017

9.6K

Area of Science:

  • Immunology
  • Pharmacology
  • Genetics

Background:

  • DX-2930 is a human monoclonal antibody targeting plasma kallikrein.
  • It is being investigated for hereditary angioedema (HAE) prophylaxis.
  • HAE is a genetic disorder characterized by recurrent swelling episodes.

Purpose of the Study:

  • To evaluate the safety and tolerability of DX-2930.
  • To assess the pharmacokinetics (PK) and pharmacodynamics (PD) of DX-2930.
  • To determine the maximum tolerated dose in healthy volunteers.

Main Methods:

  • A double-blind, placebo-controlled study involving 32 healthy subjects.
  • Single subcutaneous administration of DX-2930 or placebo across four ascending dose cohorts (0.1, 0.3, 1.0, 3.0 mg/kg).
  • Safety assessments included adverse event monitoring and laboratory tests; PK/PD evaluated plasma concentrations and kallikrein inhibition.

Main Results:

  • No dose-limiting toxicity was observed; DX-2930 was well tolerated up to 3.0 mg/kg.
  • Headache was the most frequent adverse event, occurring in 25% of subjects in both DX-2930 and placebo groups.
  • PK analysis showed dose-dependent increases in Cmax and a mean half-life of approximately 20 days; PD assays confirmed dose- and time-dependent plasma kallikrein inhibition.

Conclusions:

  • Single-dose DX-2930 up to 3.0 mg/kg is safe and well-tolerated in healthy subjects.
  • The PK/PD profile supports a long-acting biological effect suitable for HAE prophylaxis.
  • Further investigation in HAE patients is warranted.