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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Single Ascending-dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Participants
Scientific title
Secondary ID [1] 0 0
Secondary ID [2] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergy 0 0
Condition category
Condition code

Study type
Description of intervention(s) / exposure
Treatment: Drugs - REGN1908-1909
Treatment: Drugs - placebo

Experimental: Group A - Participants in group A will receive REGN1908-1909

Experimental: Group B - Participants in group B will receive placebo

Treatment: Drugs: REGN1908-1909

Treatment: Drugs: placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Change in allergic symptom scale score - The primary endpoint is the change in allergic symptom scale score at day 8
Timepoint [1] 0 0
At day 8
Secondary outcome [1] 0 0
Incidence rate of treatment-emergent adverse events (TEAEs) through day 85 in participants treated with REGN1908-1909 or placebo
Timepoint [1] 0 0
day 1 to day 85
Secondary outcome [2] 0 0
Pharmacokinetic (PK) parameters of REGN1908- REGN1909 administration (i.e. how much REGN1908-1909 is in blood over time and how the body reacts to REGN1908-1909)
Timepoint [2] 0 0
day 1 to day 85

Key inclusion criteria
1. Healthy men and women between the ages of 18 and 55

2. Positive allergen skin prick test

3. Willing and able to comply with clinic visits and study-related procedures

4. Provide signed informed consent
Minimum age
18 Years
Maximum age
55 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Persistent, chronic, or active recurring infection requiring treatment with
antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit

2. Any clinically significant (determined at the investigator's discretion) abnormalities
observed during the screening physical examination

3. Onset of a new exercise routine or major change to a previous exercise routine within
4 weeks prior to the screening visit. Patients must be willing to maintain a similar
level of exercise for the duration of the study and to refrain from unusually
strenuous exercise for the duration of the trial

4. Hospitalization for any reason within 60 days prior to the screening visit

5. Participation in any clinical research study evaluating another investigational drug
or therapy within 30 days or at least 5 half-lives (whichever is longer) of the
investigational drug prior to the screening visit

6. Any medical or psychiatric condition that in the opinion of the investigator or
Regeneron, would place the patient at risk, interfere with participation in the study
or interfere with the interpretation of study results

The information listed above is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial and not all inclusion/ exclusion
criteria are listed.

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
State/province [1] 0 0
Country [2] 0 0
New Zealand
State/province [2] 0 0
Country [3] 0 0
New Zealand
State/province [3] 0 0
Country [4] 0 0
State/province [4] 0 0
Country [5] 0 0
United Kingdom
State/province [5] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Regeneron Pharmaceuticals

Ethics approval
Ethics application status

Brief summary
The purposes of this study are to assess the efficacy, safety and tolerability of a single
dose of REGN1908-1909 in allergic adult participants, to collect information about how much
REGN1908-1909 is in blood over time and to collect information about how the body reacts to
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications