Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO7049665 · 1 trial · 1 indication
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
| Arm | Type | Description |
|---|---|---|
| RO7049665 | EXPERIMENTAL | Participants will be administered a single SC dose of RO7049665 administered in up to 4 SC injection. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered a single SC dose of matching placebo formulation administered in up to 4 SC injections. |
| Name | Type | Description |
|---|---|---|
| RO7049665 | BIOLOGICAL | A single ascending dose (starting dose 1.5 micrograms \[mcg\])of RO7049665 will be administered SC. |
| Placebo | BIOLOGICAL | Matching placebo will be administered SC once. |
Inclusion Criteria: * Male healthy volunteers, 18 to 45 years of age, inclusive; * Absence of evidence of any active or chronic disease; * Body mass index (BMI) of 18-30 kilograms per square meter (kg/m\^2), inclusive; * Contraception requirements: refrain from heterosexual intercourse or use contr...
RO7049665 is an investigational monoclonal antibody being developed by Roche Holding AG (RHHBY). It is currently in Phase 1 clinical development for use in healthy volunteers. The drug is being studied to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.
RO7049665 is being studied for use in healthy volunteers. The Phase 1 clinical trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug. It is an investigational monoclonal antibody and has not been approved for any medical condition.
RO7049665 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers.
RO7049665 is in Phase 1 clinical development. The drug is being studied in a completed Phase 1 trial involving healthy volunteers. It is an investigational monoclonal antibody and is not yet approved for any use.
RO7049665 has one completed clinical trial, NCT03221179, titled "Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7049665 in Healthy Volunteers." This Phase 1 study enrolled 49 male participants in the Netherlands and was placebo-controlled and double-blind.