A Controlled Human Rhinovirus Infection Study of 2-Deoxy-D-Glucose in Healthy Adults

NCT06375772 | Terminated Phase 2

• 1 other identifier: 2-DG-02
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Nasopharyngitis

Outcome Measures

Primary Outcomes (1)

• The difference in the rate of rhinovirus-associated illness between 2-DG and placebo

  Difference in the rate of symptomatic illness and laboratory-confirmed infection

  baseline until day 22

Secondary Outcomes (14)

• Number of infected subjects

  baseline, days 2-22 after start of dosing

• Difference in percent of infected subjects

  baseline, days 2-22 after start of dosing

• Difference in percent of days virus positive

  days 2-6

• Difference in peak nasal virus load

  days 2-6

• Difference in AUC nasal virus load

  days 2-6

Study Arms (2)

Study Drug

ACTIVE COMPARATOR

Each subject receives a multiple dose of a 3.5% 2-Deoxyglucose as nasal spray solution. The maximum daily dose is 56 mg/day if applied 4 times/day, over 7 days.

Drug: 2-Deoxy-D-glucose

Placebo

PLACEBO COMPARATOR

Each subject receives a multiple dose of placebo as nasal spray solution. The dose is corresponding to the amount of solution needed in the serum group.

Other: Placebo

Interventions

2-Deoxy-D-glucose DRUG

Intranasal administration

Also known as: 2-Deoxyglucose, 2-DG

Study Drug

Placebo OTHER

Intranasal administration

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 active asthma or chronic obstructive pulmonary disease (COPD) or any other pulmonary disease deemed by the investigator to increase the risk of participating in the study.
• Active nasal disease, e.g., nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.
• Frequent epistaxis or nasal sinus surgery within 3 months before baseline.
• Females: Pregnant, breast-feeding or intentions to become pregnant during the study.
• Evidence or history of drug or alcohol abuse.
• Positive test for drugs of abuse at screening or prior to study drug administration.

Sponsors & Collaborators

• G.ST Antivirals GmbH: lead

Study Sites (1)

Centre for Human Drug Research

Leiden, 2333, Netherlands

Location

MeSH Terms

Conditions

Common Cold

Interventions

Deoxyglucose

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Deoxy Sugars; Carbohydrates

Study Officials

• Ingrid de Visser-Kamerling, PhD

  Centre for Human Drug Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 19, 2024
• Study Start: April 2, 2024
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)