To Assess Pharmacokinetics, Safety and Tolerability of TEV-48125 in Japanese and Caucasian Healthy Subjects After a Single Subcutaneous (SC) Administration of TEV-48125

Teva Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: TEV-48125 - 2; Drug: TEV-48125 - 3; Drug: TEV-48125 - 1; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02673567

TV48125-PK-10078

Details and patient eligibility

About

This is a single center, randomized, double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125 (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy subjects.

Enrollment: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The subject is a man or woman, 18 to 55 years of age, inclusive
• The subject has a body mass index (BMI) ranging from 17.5 to 28.0 kg/m2, inclusive
• The subjects must be in a good health at screening and check-in

Additional inclusion criteria for Japanese subjects:

• Subject must be a non-naturalized Japanese citizen and hold a Japanese passport
• Subject must have/had 2 Japanese parents and 4 Japanese grandparents who are all non naturalized Japanese citizens
• Subject has been living outside of Japan for no more than 10 years

Additional inclusion criteria for Caucasian subjects:

• The subject has/had 2 Caucasian parents and 4 Caucasian grandparents. Caucasian includes White and Hispanic ethnicities.

  • Additional criteria apply, please contact the investigator for more information

Exclusion criteria

• The subject is a woman who is pregnant or lactating

• The subject is suffering from, or has a clinically significant history of, 1 or more of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, hematologic or psychiatric disorder(s)

• The subject has a known allergy or sensitivity to injected proteins, including monoclonal antibodies, or any other component of the formulation. In addition, presence of history of allergies requiring acute or chronic treatment

• Precipitation in another clinical study of a new investigational drug within 30 days (90 days for biologics) before dosing

  • Additional criteria apply, please contact the investigator for more information

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

64 participants in 4 patient groups, including a placebo group

TEV-48125 - 1

Experimental group

Description:

Dose Regimen 1

Treatment:

Drug: TEV-48125 - 1

TEV-48125 - 2

Experimental group

Description:

Dose Regimen 2

Treatment:

Drug: TEV-48125 - 2

TEV-48125 - 3

Experimental group

Description:

Dose Regimen 3

Treatment:

Drug: TEV-48125 - 3

Placebo

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: Placebo