A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants

NCT04828343 | Completed Phase 1 Results

• 1 other identifier: UP0106
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single subcutaneous (SC) dose of rozanolixizumab administered to healthy participants by manual push (MP) versus (vs) syringe driver.

Conditions

Healthy Study Participants

Keywords

Healthy Study Participants; Phase 1; rozanolixizumab; manual push; syringe driver

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

  A TEAE was defined as any adverse event (AE) with a start date/time on or after first dose of study medication until 8 weeks after dosing of study medication.

  From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)

Secondary Outcomes (6)

• Maximum Plasma Concentration (Cmax) of a Single Dose Rozanolixizumab

  Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16

• Time to Maximum Plasma Concentration (Tmax) of a Single Dose Rozanolixizumab

  Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16

• Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of a Single Dose Rozanolixizumab

  Sampling time points for plasma Pharmacokinetics were as follows: predose, immediately at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, and 16

• Baseline-corrected Area Under the Total Immunglobulin (Ig) G-time Curve

  Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57

• Percent Maximum Decrease in Total Plasma IgG (Rmin) of a Single Dose Rozanolixizumab or Placebo

  Sampling time points for total IgG were as follows: 24, 36, 48, 72, and 96 hours after start of infusion, and on Days 7, 10, 13, 16, 19, 22, 29, 43 and 57

Study Arms (4)

Cohort 1 <50 kg

EXPERIMENTAL

Study participants randomized to Cohort 1 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered with a syringe driver.

Drug: rozanolixizumab; Other: Placebo

Cohort 2 <50 kg

EXPERIMENTAL

Study participants randomized to Cohort 2 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered by manual push.

Drug: rozanolixizumab; Other: Placebo

Cohort 3 >=50 kg

EXPERIMENTAL

Study participants randomized to Cohort 3 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered with a syringe driver.

Drug: rozanolixizumab; Other: Placebo

Cohort 4 >=50 kg

EXPERIMENTAL

Study participants randomized to Cohort 4 will receive a single dose of rozanolixizumab (RLZ) or placebo (PBO) subcutaneously administered by manual push.

Drug: rozanolixizumab; Other: Placebo

Interventions

rozanolixizumab DRUG

Study participants will receive a single dose rozanolixizumab subcutaneously administered by manual push or a syringe driver.

Also known as: RLZ

Cohort 1 <50 kg; Cohort 2 <50 kg; Cohort 3 >=50 kg; Cohort 4 >=50 kg

Placebo OTHER

Study participants will receive a single dose placebo subcutaneously administered by manual push or a syringe driver.

Also known as: PBO

Cohort 1 <50 kg; Cohort 2 <50 kg; Cohort 3 >=50 kg; Cohort 4 >=50 kg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study participant must be 18 to 65 years of age, inclusive
• Study participants who are overtly healthy in the opinion of the investigator as determined by medical evaluation including medical history, a general clinical examination, including physical examination and laboratory tests, and cardiac monitoring
• Study participant has blood pressure (BP) and pulse within normal range in a supine position after 5 minutes of rest (systolic BP: 90 to 140 mmHg, diastolic BP: 50 to 90 mmHg, pulse: 40 to 90 beats per minute (bpm))
• Study participant has clinical laboratory test results within the reference ranges of the testing laboratory or not clinically significant if outside the specified ranges, in the opinion of the investigator
• Study participant's electrocardiogram (ECG) is considered "normal" or "abnormal but clinically nonsignificant" (as interpreted by the investigator)
• Study participants may be male or female
• Participant has a body mass index of 18 to 32 kg/m\^2, with a minimum body weight of 35 kg

You may not qualify if:

• History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders. Has active neoplastic disease or history of neoplastic disease within the previous 5 years of entry in the clinical study (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care approaches). Has a history of a major organ transplant or hematopoietic stem cell/marrow transplant
• Symptomatic herpes zoster within 3 months prior to Screening
• Allergies to humanized monoclonal antibodies
• Female who is pregnant or lactating
• Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions
• Evidence of active or latent tuberculosis (TB) as documented by medical history and examination
• Predicted inability to comply with being free of caffeine and ethanol from 72 hours prior to clinic admission and during the In-Clinic Period of the study
• Known hypersensitivity to oral paracetamol (acetaminophen)
• History of known inflammatory bowel disease, active diverticular disease, or a history of confirmed duodenal, gastric, or esophageal ulceration in the previous 6 months
• History of hyperprolinemia, since L-proline is a constituent of rozanolixizumab.
• Twelve-lead ECG with abnormalities considered to be clinically significant upon medical review
• Renal impairment, defined as a creatinine concentration in serum of ≥1.4 mg/dL (≥123 μmol/L) for female participants and ≥1.5 mg/dL (≥132 μmol/L) for male participants
• Known viral hepatitis (B and C) or human immunodeficiency virus 1/2 antibodies or has a past medical history or family history of primary immunodeficiency or antibodies to human immunodeficiency virus type 1 and/or type 2 at Screening
• Participant has a positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in reverse transcriptase-polymerase chain reaction on admission to the unit
• Participant has clinical signs and symptoms consistent with SARS-CoV-2 (eg, fever, dry cough, dyspnea, sore throat, fatigue) or confirmed infection by appropriate laboratory test within the previous 14 days prior to Screening or on admission

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (1)

Up0106 001

London, United Kingdom

Location

MeSH Terms

Interventions

rozanolixizumab

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a participant-blind and investigator-blind study.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 2, 2021
• Study Start: April 22, 2021
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: March 7, 2024
• Results First Posted: March 7, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)