A study to evaluate the safety, tolerability, processing by the body, and response of the body to the drug RO7497987 in single and multiple ascending doses in healthy volunteers

A Phase IA, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7497987 in single and multiple ascending doses in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN92655801

Enrollment

Registered

2021-11-29

Start date

2021-11-30

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7497987 Other

Interventions

Single Ascending Dose (SAD): RO7497987 monotherapy single dose given intravenously (IV) at Cycle 1 Day 1. Cohorts of at least 6 participants each will be treated at escalating doses of RO7497987 Mult

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age =18 years and =65 years at the time of signing Informed Consent Form (ICF) 2. A minimum weight of 40 kg at screening 3. Body mass index of 18-32 kg/m² at screening 4. Adequate hematologic and end-organ function

Exclusion criteria

Exclusion criteria: 1. History or active diseases of bone marrow disorders 2. History of malignancy within 5 years prior to screening 3. Vaccine immunization within 2 weeks prior to initiation of study drug 4. Known infection/COVID-19 positive or persistent symptoms of SARS-CoV-2 5. HIV positive 6. Active Hepatitis B or Hepatitis C infections 7. Current tobacco use 8. History or currently active of autoimmune disease 9. Significant cardiovascular disease 10. Known clinically significant liver and renal diseases

Design outcomes

Primary

Measure	Time frame
1. Percentage of participants with adverse events and severity per National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0) from screening up to approximately 13 months 2. Targeted vital signs measured using clinical examinations at every visit from study initiation up to approximately 3 months after the last dose 3. Targeted clinical laboratory test results measured using blood and urine samples at selected timepoints from study initiation up to approximately 3 months after the last dose	—

Measure

Time frame

1. Percentage of participants with adverse events and severity per National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0) from screening up to approximately 13 months 2. Targeted vital signs measured using clinical examinations at every visit from study initiation up to approximately 3 months after the last dose 3. Targeted clinical laboratory test results measured using blood and urine samples at selected timepoints from study initiation up to approximately 3 months after the last dose

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Secondary

Measure	Time frame
1. Myeloid cells in the peripheral blood following administration of RO7497987 measured using blood samples at multiple timepoints from study initiation up to approximately 3 months after the last dose 2. Serum concentration of RO7497987 measured using blood samples at multiple timepoints from study initiation up to approximately 3 months after the last dose 3. Pharmacokinetic parameters (i.e., AUC, Tmax, Cmax, CL, Vss/F, and t1/2) measured using blood samples at multiple timepoints from study initiation up to approximately 3 months after the last dose 4. Prevalence and incidence of anti-drug antibodies measured using blood samples at baseline and after initiation of study treatment, from study initiation up to approximately 13 months	—

Measure

Time frame

1. Myeloid cells in the peripheral blood following administration of RO7497987 measured using blood samples at multiple timepoints from study initiation up to approximately 3 months after the last dose 2. Serum concentration of RO7497987 measured using blood samples at multiple timepoints from study initiation up to approximately 3 months after the last dose 3. Pharmacokinetic parameters (i.e., AUC, Tmax, Cmax, CL, Vss/F, and t1/2) measured using blood samples at multiple timepoints from study initiation up to approximately 3 months after the last dose 4. Prevalence and incidence of anti-drug antibodies measured using blood samples at baseline and after initiation of study treatment, from study initiation up to approximately 13 months

—

Countries

United States of America

Contacts

Public ContactClinical Trials

global-roche-genentech-trials@gene.com+1 888-662-6728

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 1, 2026