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NCT Number: NCT07271693

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.

Recruiting

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Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Zealand Clinical Research - Christchurch

Christchurch, 8011, New Zealand

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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) (inclusive)

Inclusion criteria

Specific to Cohort A9 (East Asian Cohort):

  • Must be of ethnic Chinese, Korean, or Japanese origin
  • Must have a BW >35 kg and BMI within the range 18-32 kg/m2 (inclusive)

Exclusion criteria

  • Pregnancy, breastfeeding, or intention to become pregnant during the study or within 6 months after the final dose of study treatment
  • History of any clinically significant autoimmune, gastrointestinal, renal, hepatic, pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer or cirrhosis
  • Latent tuberculosis (TB) or potentially active TB
  • Any major illness within 1 month before the screening examination or any febrile illness within 1 week prior to the screening visit and up to first dose administration
  • Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study
  • History of hypersensitivity to biologic agents or any of the excipients in the formulation, or other allergy that contraindicates participation in the study
  • Live vaccines within 1 month of the first screening visit or during the screening period
  • Non-live vaccines within 2 weeks prior to dosing
  • Previous exposure to RO7806881
  • Positive hepatitis C virus (HCV) antibody test result
  • Positive test results for hepatitis B infection
  • Positive human immunodeficiency virus (HIV) antibody test result
  • Positive test result consistent with cytomegalovirus (CMV) or Epstein-Barr virus (EBV)

Treatment and study plan

RO7806881

Drug

RO7806881 will be administered as per the schedule specified in the protocol.

Placebo

Drug

Placebo will be administered as per the schedule specified in the protocol.

Primary outcomes

  1. SAD Part: Number of Participants With Adverse Events (AEs)

    Time frame: Up to Day 127

  2. MAD Part: Number of Participants With AEs

    Time frame: Up to Day 162

  3. SAD Part: Number of Participants With Dose-limiting Adverse Events (DLAEs)

    Time frame: Up to Day 127

  4. MAD Part: Number of Participants With DLAEs

    Time frame: Up to Day 162

Secondary outcomes

  1. SAD and MAD Parts: Serum Concentration of RO7806881

    Time frame: SAD: Up to Day 127; MAD: Up to Day 162

  2. SAD and MAD Parts: Maximum Concentration (Cmax) of RO7806881

    Time frame: SAD: Up to Day 127; MAD: Up to Day 162

  3. SAD and MAD Parts: Minimum Concentration (Cmin) of RO7806881

    Time frame: SAD: Up to Day 127; MAD: Up to Day 162

  4. SAD and MAD Parts: Area Under the Curve (AUC) From the Last Time of Dosing to the Last Measurable Concentration (AUClast) of RO7806881

    Time frame: SAD: Up to Day 127; MAD: Up to Day 162

  5. SAD and MAD Parts: Apparent Total Body Clearance (CL/F) of RO7806881

    Time frame: SAD: Up to Day 127; MAD: Up to Day 162

  6. SAD and MAD Parts: Volume of Distribution at Steady-state Conditions (Vss) of RO7806881

    Time frame: SAD: Up to Day 127; MAD: Up to Day 162

  7. SAD and MAD Parts: Dose Proportionality for AUC

    Time frame: SAD: Up to Day 127; MAD: Up to Day 162

  8. SAD and MAD Parts: Dose Proportionality for Cmax

    Time frame: SAD: Up to Day 127; MAD: Up to Day 162

  9. MAD Part: Accumulation Ratio (Racc) of RO7806881

    Time frame: Up to Day 162

  10. SAD and MAD Parts: Absolute Bioavailability of RO7806881

    Time frame: SAD: Up to Day 127; MAD: Up to Day 162

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: BP46089 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase I, Randomized, Investigator/Participant-blind, Parallel-group, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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