A first in human study of CpG ODN D35 in healthy volunteers - V1.0
Research type
Research Study
Full title
A Phase I, Double-blind, Randomised, Single Centre, Parallel-group, Single Ascending Dose, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CpG ODN D35 after Subcutaneous Administration in Healthy Male Subjects
IRAS ID
297265
Contact name
Annelize Koch
Contact email
Sponsor organisation
Drugs for Neglected Diseases initiative (DNDi)
Eudract number
2021-001179-18
ISRCTN Number
ISRCTN15458851
Duration of Study in the UK
0 years, 4 months, 25 days
Research summary
The purpose of this study is to investigate the study drug CpG ODN D35.
The main objectives of this study are as follows:
- To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of CpG ODN D35 when it is administered as a subcutaneous injection (injection into the tissue layer between the skin and muscle) at different dose strengths on one occasion.- To investigate the concentration of CpG ODN D35 in the blood, how this changes over a period of time and whether there are differences in the concentration profile between different dose strengths.
The study will consist of up to 4 groups of 8 male participants: each group investigating a different dose strength.
In this study, participants will either be given CpG ODN D35 or a placebo (which contains no active drug). Both CpG ODN D35 and the placebo will be administered in the form of one or more subcutaneous injections (injection into the fatty tissue layer between the skin and muscle).
Blood samples will be taken at set time points throughout the study in order to measure the concentration profile of CpG ODN D35 in the blood, how this changes over time and how this compares with the placebo and at each dose strength.
The results from each of the groups will be compared to determine if there are any significant differences in the safety profile of CpG ODN D35, the concentration of CpG ODN D35 in the blood, how this changes over time and whether there are any differences in these parameters at different dose strengths and in comparison with the placebo.
The purpose of the data generated in this study is to provide further information and guidance to support the study sponsor in development of the study drug.
REC name
Wales REC 1
REC reference
21/WA/0094
Date of REC Opinion
14 May 2021
REC opinion
Further Information Favourable Opinion