A controlled human rhinovirus infection study of 2-Deoxy-D-Glucose in healthy adults.

2023-509311-91-01 Protocol 2-DG-02 Therapeutic exploratory (Phase II) Ended

Start 15 Feb 2024 · End 13 Aug 2024 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol 2-DG-02

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ended
Participants planned 128
Countries 1
Sites 1

Rhinovirus-associated illness

To confirm the efficacy of 2-DG compared to placebo for the prevention of rhinovirus-associated illness.

Key facts

Sponsor
G.ST Antivirals GmbH, G.ST Antivirals GmbH
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Virus Diseases [C02]
Trial duration
15 Feb 2024 → 13 Aug 2024
Decision date (initial)
2024-02-14
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Others, Efficacy, Prophylaxis, Safety

To confirm the efficacy of 2-DG compared to placebo for the prevention of rhinovirus-associated illness.

Secondary objectives 4

  1. To evaluate the effect of 2-DG on the occurrence and course of rhinovirus infection
  2. To evaluate the effect of 2-DG on the severity of symptoms of rhinovirus infection
  3. To evaluate safety and tolerability of 2-DG administrated over 1 week in the presence of rhinovirus exposure
  4. To evaluate pharmacokinetics of 2-DG

Conditions and MedDRA coding

Rhinovirus-associated illness

Regulatory references

Scientific advice from competent authorities
Medicines And Healthcare Products Regulatory Agency, Austrian Federal Office For Safety In Health Care
EU CT numberTitleSponsor
2023-509311-91-00 A randomized, double-blind, placebo-controlled Phase 2 study using the rhinovirus challenge model to investigate the efficacy and safety of 2-Deoxy-D-glucose as pre-exposure prophylaxis. G.ST Antivirals GmbH

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Healthy male or female subjects 18 to 64 (inclusive at screening) years of age. The investigator judges the definition of healthy by detailed medical history and physical examination
  2. Women of childbearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment
  3. Signed informed consent form prior to any study-related procedures
  4. Subject is willing and able to tolerate the nasal wash procedure at screening
  5. Has the ability to communicate well with the investigator in the Dutch language and the willingness and ability to adhere to the prohibitions and restrictions specified in this protocol

Exclusion criteria 5

  1. Active smoker or history of smoking > 5 pack years
  2. Upper or lower respiratory tract infection or febrile illness (temperature ≥ 37.9 °C), in the period of 2 weeks prior to study drug administration.
  3. Presence (at screening) of serum RV-39 neutralizing antibody titer at greater than one in four (1:4) dilution
  4. Prior inoculation with a virus from the same virus family as the challenge virus
  5. Hypersensitivity/allergy to any of the investigational product ingredients

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 5

  1. Difference in number of infected subjects (defined by laboratory-confirmed infection)
  2. Difference in % of infected subjects (defined by laboratory-confirmed infection)
  3. Difference in Total Jackson Symptom Score
  4. Difference in Duration of Illness between the groups, days 2-15
  5. Occurrence of adverse events (AEs) and adverse drug reactions (ADRs)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

2-deoxy-D-glucose

PRD10960567 · Product

Active substance
2-DEOXY-D-GLUCOSE
Substance synonyms
BA-2758, 2-DEOXYGLUCOSE
Other product name
2-DG
Pharmaceutical form
NASAL SPRAY, SOLUTION
Route of administration
NASAL SPRAY
Max daily dose
56 mg milligram(s)
Max total dose
392 mg milligram(s)
Max treatment duration
7 Day(s)
Authorisation status
Not Authorised
MA holder
G.ST ANTIVIRALS GMBH
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo for 2-deoxy-D-glucose

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

G.ST Antivirals GmbH

Sponsor organisation
G.ST Antivirals GmbH
Address
Dr.-Bohr-Gasse 7, Landstrasse Landstrasse
City
Vienna
Postcode
1030
Country
Austria

Scientific contact point

Organisation
G.ST Antivirals GmbH
Contact name
G. Gualdoni

Public contact point

Organisation
G.ST Antivirals GmbH
Contact name
G. Gualdoni

G.ST Antivirals GmbH

Sponsor organisation
G.ST Antivirals GmbH
Address
Dr.-Bohr-Gasse 7, Landstrasse Landstrasse
City
Vienna
Postcode
1030
Country
Austria

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ended 128 1
Rest of world — 0 —

Investigational sites

Netherlands

1 site · Ended
Centre for Human Drug Research
Infectious Diseases, Zernikedreef 8, 2333 CL, Leiden

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2024-02-15 2024-02-26

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
Summary of Results (ENG) - 2023-509311-91-01
SUM-91926
 2025-07-25T09:56:26 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
Summary of Results for Laypersons (ENG) - 2023-509311-91-01 2025-07-25T09:57:59 Submitted Laypersons Summary of Results
Samenvatting van de resultaten voor leken (NL) - 2023-509311-91-01 2025-07-25T09:59:16 Submitted Laypersons Summary of Results

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) Samenvatting van de resultaten voor leken (NL) - 2023-509311-91-01 1
Laypersons summary of results (for publication) Summary of Results for Laypersons (ENG) - 2023-509311-91-01 1
Summary of results (for publication) Summary of Results_2023-509311-91-01 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-01-15 Netherlands Acceptable
2024-02-14
 2024-02-14