A Controlled Human Rhinovirus Infection Study of 2-Deoxy-D-Glucose in Healthy Adults (NCT06375772) | Clinical Trial Compass
TerminatedPhase 2
A Controlled Human Rhinovirus Infection Study of 2-Deoxy-D-Glucose in Healthy Adults
Stopped: Re-calculated sample size
Netherlands64 participantsStarted 2024-04-02
Plain-language summary
2-DG-02 is a randomized, placebo-controlled, double-blind Phase 2 study to investigate the efficacy and safety of 2-Deoxy-D-Glucose as a pre-exposure prophylaxis using the rhinovirus challenge model in healthy study participants.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion Criteria:
* Healthy male or female subjects 18 to 64 (inclusive at screening) years of age.
* Women of childbearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception until end of study.
* Signed informed consent form prior to any study-related procedures.
Exclusion Criteria:
* Active smoker or history of smoking \> 5 pack years.
* Upper or lower respiratory tract infection or febrile illness
* Presence (at screening) of serum RV-39 neutralizing antibody titer at greater than one in four (1:4) dilution.
* Nasopharyngeal swab indicative for Influenza or SARS-CoV2 infection by rapid antigen test at baseline.
* Prior inoculation with a virus from the same virus family as the challenge virus.
* Any anatomic or neurologic abnormality impairing the gag reflex, or associated with an increased risk of aspiration, or any abnormality significantly altering the anatomy of the nose or nasopharynx in a substantial way that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge.
* Positive Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
* Any confirmed or suspected disease or condition associated with immune system impairment, including auto-immune diseases, asplenia or recurrent severe infections.
* Active allergic rhinitis or hay fever.
* Medical history or a…
What they're measuring
1
The difference in the rate of rhinovirus-associated illness between 2-DG and placebo