A Randomized Cross-Over Study to Evaluate Local Tolerability Following Subcutaneous Administration of TV-46046
A Randomized Cross-Over Study to Evaluate Local Tolerability Following Subcutaneous Administration of TV-46046
The purpose of this study is to evaluate the local tolerability associated with the SC administration of TV-46046, and inform next steps of the TV-46046 development program.
Eligible participants will be enrolled and receive 1 of each of the 4 SC study injections in each abdominal quadrant approximately 1 hour apart: 120 milligrams (mg)/0.3 milliliter (mL) of TV-46046, 60 mg/0.3 mL of 1:1 saline diluted TV-46046, 0.3 mL of TV-46046 Placebo and 104 mg/0.65 mL Depo-subQ 104 per the assigned sequence.
Inclusion Criteria:
Participant has a low risk of pregnancy (that is, sterilized, in exclusively same-sex partnership, in menopause and/or post-menopausal, abstinent, in a monogamous relationship with vasectomized partner, using nonhormonal intrauterine device [IUD], or consistent use of condoms)
Participant is not pregnant and does not have desire to become pregnant in the subsequent 18 months
Participant had a normal mammogram within the last year, if 40 years or older
Participant has no skin disorders or skin allergies
Exclusion Criteria:
Participant has hypertension
Participant has ischemic heart disease or a history of ischemic heart disease
Participant has a history of stroke
Participant has a history of thromboembolic event(s)
Participant has systemic lupus erythematosus
Participant has rheumatoid arthritis and is undergoing immunosuppressive therapy
Participant has migraine with aura
Participant has unexplained vaginal bleeding
Participant has diabetes
Participant has a strong family history of breast cancer
Participant has cervical cancer or a history of cervical cancer
Participant has severe cirrhosis (decompensated) or liver tumors
Participant has known significant renal disease
Participant has a history of diagnosed clinical depression or bipolar disorder, with or without suicidal ideation, and/or history of suicide attempt
Participant is currently using hormonal contraception
Participant had an injection of DMPA (Depo-Provera CI or Depo-subQ 104) in the past 12 months; or combined injectable in the last 3 months
Participant is chronically using pain medication
Participant has a plan to move to another location in the next 18 months