Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-295 · 3 trials · 2 indications
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Number of participants with abnormal change from baseline in vital sign measurements like heart rate, systolic and diastolic blood pressure will be assessed.
12-lead resting ECG will be recorded.
Number of participants with abnormal change in clinical laboratory test results like biochemistry, hematology will be assessed.
Cmax of ABBV-295
Tmax of ABBV-295
Ctrough of ABBV-295
BETA of ABBV-295
t1/2 of ABBV-295
AUC of ABBV-295
AUCtau of ABBV-295
Dose normalized Cmax of ABBV-295 will be assessed.
Dose normalized AUC of ABBV-295 will be assessed.
Incidence of ADAs will be assessed.
Percent change in body weight (kg) will be assessed.
| Arm | Type | Description |
|---|---|---|
| ABBV-295 Part 1 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 for 12 weeks. |
| Placebo for ABBV-295 Part 1 | EXPERIMENTAL | Participants will receive subcutaneous doses of placebo for 12 weeks. |
| ABBV-295 Part 2 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 for 12 weeks. |
| Placebo for ABBV-295 Part 2 | EXPERIMENTAL | Participants will receive subcutaneous doses of placebo for 12 weeks. |
| ABBV-295 with Levonorgestrel and Ethinyl Estradiol | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 with levonorgestrel and ethinyl estradiol for 68 days. |
| ABBV-295 or Placebo-Group 1 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
| ABBV-295 or Placebo-Group 2 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
| ABBV-295 or Placebo-Group 3 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
| ABBV-295 or Placebo-Group 4 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
| Name | Type | Description |
|---|---|---|
| ABBV-295 | DRUG | Subcutaneous Injections |
| Placebo for ABBV-295 | DRUG | Subcutaneous Injections |
| Levonorgestrel/Ethinyl Estradiol | DRUG | Oral Tablet |
| Placebo | DRUG | Subcutaneous Injections |
Inclusion Criteria: * Japanese participant must be first-or second-generation Japanese of full Japanese parentage. 1. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. 2. Second-generation participants b...
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