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Recruiting NCT07271693

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

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RO7806881, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

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

Primary outcome measures

  • SAD Part: Number of Participants With Adverse Events (AEs) [Time frame: Up to Day 127]
  • MAD Part: Number of Participants With AEs [Time frame: Up to Day 162]
  • SAD Part: Number of Participants With Dose-limiting Adverse Events (DLAEs) [Time frame: Up to Day 127]
  • MAD Part: Number of Participants With DLAEs [Time frame: Up to Day 162]
Secondary outcome measures (10)
  • SAD and MAD Parts: Serum Concentration of RO7806881 [Time frame: SAD: Up to Day 127; MAD: Up to Day 162]
  • SAD and MAD Parts: Maximum Concentration (Cmax) of RO7806881 [Time frame: SAD: Up to Day 127; MAD: Up to Day 162]
  • SAD and MAD Parts: Minimum Concentration (Cmin) of RO7806881 [Time frame: SAD: Up to Day 127; MAD: Up to Day 162]
  • 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]
  • SAD and MAD Parts: Apparent Total Body Clearance (CL/F) of RO7806881 [Time frame: SAD: Up to Day 127; MAD: Up to Day 162]
  • 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]
  • SAD and MAD Parts: Dose Proportionality for AUC [Time frame: SAD: Up to Day 127; MAD: Up to Day 162]
  • SAD and MAD Parts: Dose Proportionality for Cmax [Time frame: SAD: Up to Day 127; MAD: Up to Day 162]
  • MAD Part: Accumulation Ratio (Racc) of RO7806881 [Time frame: Up to Day 162]
  • SAD and MAD Parts: Absolute Bioavailability of RO7806881 [Time frame: SAD: Up to Day 127; MAD: Up to Day 162]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

New Zealand · 1 center
  • New Zealand Clinical Research - Christchurch — Christchurch

Identifiers

NCT: NCT07271693 · BP46089

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗