Safety and Tolerability of XmAb®7195 in Adult Healthy Volunteers and Adult Subjects With a History of Allergic Rhinitis and/or Allergic Conjunctivitis and/or Atopic Dermatitis
Status: | Completed |
---|---|
Conditions: | Allergy, Psoriasis, Ocular, Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery, Ophthalmology, Otolaryngology |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 1/25/2017 |
Start Date: | May 2014 |
End Date: | September 21, 2015 |
A Randomized, Double-Blinded, Placebo-Controlled, Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of XmAb®7195
This first-in-human (FIH) study is a randomized, double-blinded, placebo-controlled,
ascending dose study to investigate the safety, tolerability, and pharmacokinetics of
XmAb7195 in adult healthy volunteers and in adult subjects with elevated IgE levels.
ascending dose study to investigate the safety, tolerability, and pharmacokinetics of
XmAb7195 in adult healthy volunteers and in adult subjects with elevated IgE levels.
Inclusion Criteria:
- Adult males and females 18 to 50 years of age
- Parts 1 and 3: Healthy subjects with no clinically significant abnormality identified
on medical or laboratory evaluation and no history of any clinically significant
disorder, condition, or disease that would pose a risk to subject safety or interfere
with the study evaluation, procedures, or completion;
- Part 2: Otherwise healthy male and female subjects with a history of allergic
rhinitis and/or allergic conjunctivitis and/or atopic dermatitis with an elevated
serum IgE
- Subjects who are able and willing to give written informed consent;
- Subjects who have the ability to complete all study assessments;
- Subjects who are willing to forego other forms of experimental treatment during the
study.
Exclusion Criteria:
- Subjects who have a clinically relevant history or presence of respiratory,
gastrointestinal, renal, hepatic, hematological, lymphatic, neurological,
cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological,
dermatological, connective tissue diseases, or disorders (other than allergic
rhinitis and/or conjunctivitis and/or atopic dermatitis in Part 2) that would pose a
significant risk to subject safety or significantly interfere with the study
evaluation, procedures, or completion
- Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus
(HCV) antibody and/or human immunodeficiency virus (HIV) Type I or Type II tests at
Screening;
- Subjects who do not agree to use medically acceptable methods of contraception (as
defined in the protocol);
- Subject is pregnant or breast feeding, or planning to become pregnant within 3 months
of administration of XmAb7195;
- Subjects who have used any investigational drug in any clinical trial within 8 weeks
prior to admission (Day -1), or have used an experimental monoclonal antibody;
- Subjects with prior exposure to a monoclonal antibody;
- Subjects with a history of anaphylaxis;
- Subjects who have received live vaccines ≤ 3 months from Screening;
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