Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized, double-blind, placebo-controlled study will evaluate the safety and pharmacokinetics of RG7667 in healthy volunteers. Subjects will be randomized in cohorts to receive either single/multiple doses of RG7667 intravenously or placebo. Anticipated time on study treatment is up to 57 days with a 12-week follow-up.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| RG7667 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Single/multiple doses |
| |
| RG7667 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | up to 141 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration-time curve (AUC) | up to 141 days | |
| Pharmacokinetic: Maximum serum concentration (Cmax) | up to 141 days | |
| Pharmacokinetic: Time to maximum serum concentration (tmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daytona Beach | Florida | 32117 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26055360 | Derived | Ishida JH, Burgess T, Derby MA, Brown PA, Maia M, Deng R, Emu B, Feierbach B, Fouts AE, Liao XC, Tavel JA. Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of RG7667, an Anticytomegalovirus Combination Monoclonal Antibody Therapy, in Healthy Adults. Antimicrob Agents Chemother. 2015 Aug;59(8):4919-29. doi: 10.1128/AAC.00523-15. Epub 2015 Jun 8. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000623144 | RG7667 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Single/multiple ascending doses |
|
| up to 141 days |
| Pharmacokinetic: Apparent clearance (CL/F) | up to 141 days |
| Pharmacokinetic: Terminal half-life (t½) | up to 141 days |
| Honolulu |
| Hawaii |
| 96813 |
| United States |
| Evansville | Indiana | 47710 | United States |
| Dallas | Texas | 75247 | United States |
| Madison | Wisconsin | 53704 | United States |