Phase 1
Completed N=36
A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants
Source: ClinicalTrials.gov NCT04023994 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs) — 80.0; 75.0; 50.0; 83.3 Percentage of Participants
Summary
Study BP41192 is a randomized, adaptive, placebo-controlled parallel group study to investigate the safety, tolerability, immunogenicity and pharmacokinetics of single-ascending intravenous (IV) doses of RO7126209 in healthy participants. RO7126209 is being developed for the treatment of Alzheimer's Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
80.0; 75.0; 50.0; 83.3; 100.0; 100.0 | — |
| SECONDARY Concentration at the End of Infusion (Cend) of RO7126209 |
1.80; 7.93; 22.2; 85.7; 160 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From Zero to 24 h Postdose (AUC0-24h) of RO7126209 |
27.1; 124; 325; 1170; 2340 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From Zero to 168h Postdose (AUC0-168h) of RO7126209 |
78.0; 350; 807; 2940; 6190 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Measurable Concentration (AUC0-last) of RO7126209 |
86.9; 402; 933; 3380; 7070 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) |
89.1; 417; 947; 3380; 7080 | — |
| SECONDARY Terminal Rate Constant (Lambda z) of RO7126209 |
0.0103; 0.00625; 0.00690; 0.00409; 0.00436 | — |
| SECONDARY Apparent Terminal Half-Life (T1/2) of RO7126209 |
67.1; 111; 100; 170; 159 | — |
| SECONDARY Total Body Clearance Calculated as Dose/AUC (CL) of RO7126209 |
1.14; 0.965; 1.28; 1.07; 1.03 | — |
| SECONDARY Volume of Distribution at Steady-State (Vss) of RO7126209 |
88.6; 90.3; 108; 88.7; 85.3 | — |
| SECONDARY Cerebrospinal Fluid (CSF) Concentration of RO7126209 |
0.00414; 0.0202; 0.047; 0.105; 0.284; 0.00228 | — |
| SECONDARY Percentage of Participants With Anti-RO7126209 Antibodies (ADAs) |
50.0; 25.0; 66.7; 83.3; 83.3 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, ophthalmologic examination, hematology, blood chemistry, coagulation, serology, and urinalysis.
- Body mass index (BMI) of 18-30 kg/m2 inclusive
- During the treatment period and until the final follow up visit, agreement to: (1) Remain abstinent or use contraceptive measures such as a condom plus an additional contraceptive method that together result in a failure rate of =1.5 x the upper limit of normal (ULN) or abnormal total bilirubin unless due to Gilbert's disease.
- Any clinically relevant history of hypersensitivity or allergic reactions, either spontaneous or following drug administration, or exposure to foods or environmental agents.
- History of hypersensitivity to biologic agents or any of the excipients in the formulation.
- History of raised intra-cerebral pressure or vertebral joint pathology
- Use of prohibited medication or herbal remedies as described in the section of concomitant medications
- Prior administration of gantenerumab (RO4909832)
- Any vaccination within two months prior to Day 1
- Participation in an investigational drug medicinal product or medical device study within 30 days before screening or within seven times the elimination half-life if known, whichever is longer.
- Participants who regularly smoke more than 5 cigarettes daily or equivalent and are unable or unwilling not to smoke during the in-house period.
- Donation or loss of blood over 500 mL within three months prior to Day 1 and donation of blood for the duration of the study until follow-up.
- Evidence of clinically significant brain magnetic resonance imaging (MRI) findings, including lacunar infarct, territorial infarct or macroscopic hemorrhage, microbleed or area of leptomeningeal hemosiderosis, or deep white matter lesions corresponding to an overall Fazekas score of ≥ 2.
- Claustrophobia, presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body that would contraindicate an MRI scan.
Data sourced from ClinicalTrials.gov (NCT04023994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.