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Completed

NCT Number: NCT04605718

A Study To Investigate The Safety, Tolerability And Pharmacokinetics (PK) Of RO7223280 Following Intravenous Administration In Healthy Participants

The Study consists of 3 Parts: Part 1 (Single Ascending Dose/SAD), Part 2 (Multiple Ascending Dose/MAD), and Part 3 (Elderly). Part 1 will investigate the safety, tolerability and PK of single-ascending intravenous (IV) doses of RO7223280 in healthy participants. Part 2 will investigate the safety, tolerability and PK of multiple-ascending IV doses of RO7223280 in healthy participants. Part 2 will start after the initial completion of Part 1 (SAD). Progression from Part 1 to Part 2 will be based on a satisfactory review of all available safety, tolerability, and PK data by the Investigator and the Sponsor from Part 1. The starting dose for Part 2 will be administered as 1-hour IV infusion; as it has been established on the basis of all available safety, tolerability, and PK data in Part 1 (SAD). Part 3 will investigate the safety, tolerability and PK of a single IV dose of RO7223280 in healthy elderly participants. A single IV dose of RO7223280 administered over 1 hour was selected, within the range of previously explored doses in Part 1 (SAD).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Parts 1 (SAD) and 2 (MAD): 18 to 64 years of age, inclusive. Part 3 (Elderly): 65 years of age and older
  • Healthy participants in Part 1 (SAD) and Part 2 (MAD). Health status is defined by 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, hematology, blood chemistry, serology, coagulation, and urinalysis. Healthy participants in Part 3 (Elderly). Participants must be in reasonably good health as determined by the Investigator based on medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology,blood chemistry, serology, coagulation, and urinalysis. Participants with mild, chronic, stable disease (e.g., controlled hypertension, controlled diabetes mellitus) may be enrolled if deemed medically prudent by the Investigator.
  • In Part 1 (SAD) and Part 2 (MAD) participants must weigh at least 50 kg and must have a body mass index (BMI) within the range of 18 to 32 kg/m^2 (inclusive). In Part 3 (Elderly), participants must weigh at least 50 kg with no restrictions regarding the BMI.
  • During the treatment period and for at least 90 days after the final dose of RO7223280 or placebo, male participants (whether surgically sterilized or not) agree to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm at least 90 days after last dose.

Exclusion criteria

  • For Part 1 (SAD) and Part 2 (MAD), history of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis.For Part 3 (elderly), participants must be in reasonably good health as determined by the Investigator based on a detailed medical history. Participants with mild, chronic, stable disease and on stable medication may be enrolled if deemed medically prudent by the Investigator.
  • In Part 1 (SAD) and Part 2 (MAD), use of glucocorticoids and other immunosuppressive medications is prohibited within 30 days (or within 5 times the elimination half-life, whichever is longer), prior to Day 1. In Part 3 (Elderly Cohort), the systemic use of glucocorticoids and other immunosuppressive medications is prohibited within 30 days (or within 5 times the elimination half-life, whichever is longer), prior to Day 1.
  • Participation in an investigational drug medicinal product or medical device study within 30 days prior to screening or within 5 times the elimination half-life if known, whichever is longer.
  • In Part 1 (SAD) and Part 2 (MAD), confirmed (based on the average of 3 consecutive measurements) systolic blood pressure (SBP) greater than 140 or less than 90 mmHg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mmHg at screening. In Part 3 (Elderly), confirmed (based on the average of 3 consecutive measurements) systolic blood pressure (SBP) greater than 160 or less than 80 mmHg, and diastolic blood pressure (DBP) greater than 90 or less than 40 mmHg at screening.
  • Confirmed (based on the average of 3 consecutive measurements) resting pulse greater than 100 bpm or less than 40 bpm at screening.
  • Positive for HIV or Hepatitis B/C infections.
  • Donation of blood or blood products for transfusion over 500 mL within 3 months prior to first study drug administration and for the duration of the study.
  • Any clinically significant history of hypersensitivity or allergic reactions, either spontaneous or following study drug administration, or from exposure to food or environmental agents.

Treatment and study plan

RO7223280

Drug

For Part 1 (SAD) and Part 2 (MAD), RO7223280 will be administered by intravenous (IV) infusion at escalating doses from 10mg to 4800mg, as per the dosing schedules described above. These are putative doses and the maximum daily dose that must not be exceeded is 5000mg. For Part 3 (Elderly), RO7223280 will be administer as one single IV dose of 300 mg.

Primary outcomes

  1. Percentage of Participants with Adverse Events (AEs)

    Time frame: Up to 19 months

Secondary outcomes

  1. Plasma Concentrations of RO7223280 at specified timepoints

    Time frame: Up to 19 months

  2. Urine Concentrations of RO7223280 at specified timepoints

    Time frame: Up to 19 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Sponsor-Open, Adaptive, Single- And Multiple-Ascending Dose, Placebo-Controlled Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of RO7223280 Following Intravenous Administration In Healthy Participants

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2020
Registry last updated
Apr 18, 2023

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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