Approval Probability
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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 developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in healthy male volunteers in the Netherlands. The specific disease or condition it is intended to treat has not been publicly disclosed, and it remains in early-stage clinical development.
RO7049665 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating this monoclonal antibody. No partnership or licensing arrangement for RO7049665 has been disclosed.
RO7049665 is in Phase 1 clinical development. Its only recorded trial, NCT03221179, has been completed. The program has not advanced beyond this early stage, and no later-phase studies have been initiated. RO7049665 is investigational and has not been approved by the FDA for any indication.
RO7049665 has been evaluated in one completed Phase 1 trial, NCT03221179, titled Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7049665 in Healthy Volunteers. The trial enrolled 49 participants in the Netherlands, was randomized, double-blind, and placebo-controlled, and restricted enrollment to healthy male volunteers aged 18 years and older.
No. RO7049665 is an investigational monoclonal antibody in Phase 1 development and has not been approved by the FDA. Its only clinical trial, NCT03221179, has been completed. The program remains in early-stage clinical development, and no regulatory submissions or approvals have been announced.