A phase 2a study of CR9114 in healthy adult participants

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Leyden Laboratories B.V.

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Metabolism [G03]

Trial duration

10 Jul 2023 → 23 Jan 2024

Decision date (initial)

2023-07-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To determine the effect of CR9114 on reducing the incidence of MMID.
To determine the safety and tolerability of CR9114.

Secondary objectives 4

1. To determine the overall effect of CR9114 on measurements of virological outcomes.
2. To determine the overall effect of CR9114 on measurements of disease severity.
3. To evaluate the PK profile of IN administration of CR9114.
4. To evaluate systemic ADA responses to CR9114.

Conditions and MedDRA coding

Influenza virus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male or female, between 18 and 55 years old at screening, extremes included.
2. Body Mass Index (BMI) within normal range: 19.0 ≤ BMI ≤ 30.0 kg/m2 at screening and with a minimum weight of 50.0 kg.
3. Healthy in the investigator’s clinical judgment, as confirmed by medical history, physical examination, vital signs, 12-lead ECG and laboratory assessments performed at screening and/or pre-randomization.
4. Negative hepatitis panel including hepatitis B Virus surface antigen (HBsAg), anti-hepatitis B virus core (HBc) Ab, and anti-hepatitis C virus (HCV) Abs (with reflex HCV RNA, ie, positive for HCV Abs is allowed if negative for HCV RNA) and negative human immunodeficiency virus (HIV) Type 1 and Type 2 Ab screens at screening.

Exclusion criteria 4

1. Any reason that would limit the participant’s ability to complete the trial or might interfere with the primary trial objectives for safety of the trial participant based on the opinion of the investigator.
2. History of severe local or systemic reactogenicity to any medication (eg, anaphylaxis, respiratory difficulties, angioedema).
3. Known allergy or hypersensitivity to any component of IP or viral challenge agent, including known or suspected egg allergies.
4. Presence of nasal polyps or significant nasal abnormalities or facial muscular paralysis (eg, Bell’s Palsy) and/or history of chronic sinusitis or chronic use (at least 14 days in the 2 months prior to screening) of nasally applied medications.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Incidence of MMIDa as measured by the InFLUenza Patient Reported Outcome (FLU-PRO) Plus©.
2. Frequency and severity of treatment-emergent adverse events (TEAE) and SAEs.

Secondary endpoints 12

1. Area under the curve (AUC) of the influenza ribonucleic acid (RNA) log10 viral load, Peak influenza RNA log10 viral load, and influenza RNA log10 viral load actual values by time/visit by real-time quantitative reverse transcription PCR (qRT-PCR) starting on the second day after challenge (Day 3) until discharge (Day 11).
2. Proportion of participants with infection following challenge virus inoculation as determined by qRT-PCR. Infection is defined as at least 2 consecutive qRT-PCR positive nasopharyngeal swabs starting on the second day after challenge (Day 3).
3. Viral shedding duration by qRT-PCR and qCulture.
4. Viral shedding quantitation by qRT-PCR and qCulture.
5. Symptom duration/time to onset of symptoms/time to symptom resolution/time to peak symptoms/peak symptom score/total clinical symptom score by day/FLU-PRO domain/system score as measured by the FLU-PRO Plus©.
6. Total number of symptoms experienced with or without laboratory-confirmed influenza illness as measured by the FLU-PRO Plus© and qRT-PCR.
7. Number of participants with upper respiratory tract infection, lower respiratory tract infection, systemic illness as measured by the FLU-PRO Plus©.
8. Proportion of participants with FLU-PRO Plus© score 3 or higher among participants with and without laboratory-confirmed influenza illness as measured by the FLU-PRO Plus© and qRT-PCR.
9. Proportion of participants without symptoms as measured by the FLU-PRO Plus©.
10. Proportion of participants without laboratory-confirmed influenza as measured by qRT-PCR.
11. PK of CR9114 in serum.
12. Presence of anti-CR9114 Abs in serum.

Investigational products

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

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Leyden Laboratories B.V.

Sponsor organisation

Leyden Laboratories B.V.

Address

Galileiweg 8

City

Leiden

Postcode

2333 BD

Country

Netherlands

Scientific contact point

Organisation

Leyden Laboratories B.V.

Contact name

Zoltán Magyarics

Public contact point

Organisation

Leyden Laboratories B.V.

Contact name

Zoltán Magyarics

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

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

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

Layperson summary Annex V

Documents 3 files

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

Application history

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