Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02345928 | A Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic Dermatitis | PHASE1 | COMPLETED | 108 | — | — | Aug 5, 2014 | Mar 16, 2017 | Nov 16, 2020 | 7 | Belgium, Germany |
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose 1 | EXPERIMENTAL | Drug CNTO7160 or Placebo administered IV infusion Dose 1. |
| Part 1: Dose 2 | EXPERIMENTAL | Drug CNTO7160 or Placebo administered IV infusion Dose 2. |
| Part 1: Dose 3 | EXPERIMENTAL | Drug CNTO7160 or Placebo administered IV infusion Dose 3. |
| Part 1: Dose 4 | EXPERIMENTAL | Drug CNTO7160 or Placebo administered IV infusion Dose 4. |
| Part 1: Dose 5 | EXPERIMENTAL | Drug CNTO7160 or Placebo administered IV infusion Dose 5. |
| Part 1: Dose 6 | EXPERIMENTAL | Drug CNTO7160 or Placebo administered IV infusion Dose 6. |
| Part 1: Dose 7 | EXPERIMENTAL | Drug CNTO7160 or Placebo administered IV infusion Dose 7. |
| Part 1: Dose 8 | EXPERIMENTAL | Drug CNTO7160 or Placebo administered IV infusion Dose 8. |
| Part 1: Dose 9 | EXPERIMENTAL | Drug CNTO7160 or Placebo administered IV infusion Dose 9. |
| Part 2 (Asthma): Dose 1 | EXPERIMENTAL | Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks). |
| Part 2 (Asthma): Dose 2 | EXPERIMENTAL | Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks). |
| Part 2 (Atopic Dermatitis): Dose 1 | EXPERIMENTAL | Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks). |
| Part 2 (Atopic Dermatitis): Dose 2 | EXPERIMENTAL | Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks). |
| Name | Type | Description |
|---|---|---|
| Part 1: CNTO 7160 | DRUG | Participants will receive Drug CNTO7160 administered IV infusion at escalating doses (with a starting dose of 0.001 mg/kg). |
| Part 2 (Asthma): CNTO 7160 | DRUG | Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks). |
| Part 2 (Atopic Dermatitis): CNTO 7160 | DRUG | Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks). |
| Part 1 and Part 2: Placebo | DRUG | Participants will receive single IV infusion of placebo matched to CNTO 7160. |
Inclusion Criteria: * Part 1 (Healthy Participants): Participant must have a body weight in the range of 50 to 100 kilogram (kg) inclusive and have a body mass index (BMI) of 19 to 30 kilogram per meter square (kg/m\^2) inclusive * Part 1 (Healthy Participants): Participant must be healthy on the b...