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RO7806881

Phase 1

Healthy Volunteers | Small molecule | Other |Roche Holding AG|Last Updated: Aug 21, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment128

FDA Designations

No designations recorded

Clinical trial landscape

RO7806881 · 1 trial · 1 indication

Phase 1 1
NCT07271693A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy ParticipantsHealthy Volunteers
RECRUITING128 Analytics
PHASE1RECRUITING
A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

SAD Part: Number of Participants With Adverse Events (AEs)
Up to Day 127
MAD Part: Number of Participants With AEs
Up to Day 162
SAD Part: Number of Participants With Dose-limiting Adverse Events (DLAEs)
Up to Day 127
MAD Part: Number of Participants With DLAEs
Up to Day 162

Secondary Endpoints

SAD and MAD Parts: Serum Concentration of RO7806881
SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Maximum Concentration (Cmax) of RO7806881
SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Minimum Concentration (Cmin) of RO7806881
SAD: Up to Day 127; MAD: Up to Day 162
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RO7806881: Single Ascending Dose (SAD)EXPERIMENTALParticipants will receive single doses of RO7806881, at 8 dose levels across 9 different cohorts (A1-A9) including one optional SAD cohort of East Asian participants (Cohort A9).
Placebo: SADPLACEBO_COMPARATORParticipants will receive single doses of placebo, matched to each of the 8 dose levels of RO7806881.
RO7806881: Multiple Ascending Doses (MAD)EXPERIMENTALParticipants will receive multiple doses of RO7806881, at 4 dose levels across 4 different cohorts (B1-B4), per the predefined dosing regimen.
Placebo: MADPLACEBO_COMPARATORParticipants will receive multiple doses of placebo, matched to each of the 4 dose levels of RO7806881, per the predefined dosing regimen.

Interventions

NameTypeDescription
RO7806881DRUGRO7806881 will be administered as per the schedule specified in the protocol.
PlaceboDRUGPlacebo will be administered as per the schedule specified in the protocol.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants must be males or females who are overtly healthy as determined by medical evaluation * Participants must have body weight (BW) ≥ 40 kilograms (kg) (not applicable to Cohort A9) and body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m\^2) (...

Countries:New Zealand
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Recent Changes (Last 90 Days)

LOWAug 21, 2026NCT07271693lastUpdatePostDate: changed
LOWAug 21, 2026NCT07271693lastUpdatePostDate: changed

Frequently asked questions about RO7806881

What is RO7806881?

RO7806881 is an investigational small molecule being developed by Roche Holding AG (ticker: 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.

Who makes RO7806881?

RO7806881 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 1 clinical trial to assess the drug's safety and other properties in healthy participants.

What phase is RO7806881 in?

RO7806881 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is currently recruiting participants to evaluate the drug's safety, tolerability, and how it is processed by the body.

What clinical trials is RO7806881 in?

RO7806881 is being studied in one active Phase 1 clinical trial, identified as NCT07271693. This trial is titled 'A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants' and is currently recruiting in New Zealand.

Is RO7806881 being tested in healthy volunteers?

Yes, RO7806881 is being tested in healthy volunteers. The Phase 1 clinical trial NCT07271693 is specifically designed for healthy participants aged 18 years and older. The study is placebo-controlled, double-blind, and randomized, with a total planned enrollment of 128 participants.