NCT04828343 is a Phase 1 clinical trial of rozanolixizumab in Healthy Study Participants, sponsored by UCB Biopharma SRL.

Who is sponsoring NCT04828343?

NCT04828343 is sponsored by UCB Biopharma SRL.

What drugs are being tested in NCT04828343?

Interventions in NCT04828343: rozanolixizumab, Placebo.

What condition does NCT04828343 study?

NCT04828343 studies Healthy Study Participants.

Is NCT04828343 still recruiting?

NCT04828343 is currently completed. Last updated 7 March 2024.

Are results published for NCT04828343?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-03-07 · How we verify

NCT04828343

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 7 March 2024

What this trial tests

Phase 1 trial testing rozanolixizumab in Healthy Study Participants in 32 participants. Completed in 11 April 2022.

Timeline

22 April 2021

Primary endpoint
11 April 2022

11 April 2022

Quick facts

Lead sponsor	UCB Biopharma SRL
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	32
Start date	22 April 2021
Primary completion	11 April 2022
Estimated completion	11 April 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

rozanolixizumab — full drug profile →
Placebo

Conditions studied

Healthy Study Participants — all drugs for Healthy Study Participants →

Sponsor

UCB Biopharma SRL — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy Study Participants. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Primary · From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57)

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.

Group	Value	95% CI
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)	83.3
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)	50.0
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)	100
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)	50.0
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)	83.3
Cohort 3: Syringe Driver- PBO (>=50 kg)	0
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)	83.3
Cohort 4: Manual Push- PBO (>=50 kg)	100

Maximum Plasma Concentration (Cmax) of a Single Dose Rozanolixizumab Secondary · 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

Cmax was the maximum plasma concentration of a single dose rozanolixizumab. Cmax was measured in micrograms per millilitre per milligram (ug/mL/mg).

Group	Value	95% CI
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)	0.03352	± 52.8
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)	0.004066	± 127.0
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)	0.007293	± 644.1
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)	0.02752	± 82.2

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

tmax was the time to maximum plasma concentration of a single dose rozanolixizumab.

Group	Value	95% CI
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)	60.10	36.0 – 72.4
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)	48.03	36.0 – 72.1
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)	72.00	36.0 – 96.3
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)	72.00	36.0 – 96.1

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

AUC0-t was the area under the plasma concentration-time curve from time zero to time t of a single dose rozanolixizumab.

Group	Value	95% CI
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)	2.408	± 55.4
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)	0.1436	± 266.7
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)	0.4223	± 687.0
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)	2.111	± 80.5

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

Area under the baseline-corrected total IgG response curve from time 0 to time t.

Group	Value	95% CI
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)	-190.6	± 66.10
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)	NA	± NA
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)	-101.0	± 118.4
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)	NA	± NA
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)	-141.8	± 52.99
Cohort 3: Syringe Driver- PBO (>=50 kg)	NA	± NA
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)	-168.8	± 49.70
Cohort 4: Manual Push- PBO (>=50 kg)	NA	± NA

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

Rmin was the maximum (max) decrease in total plasma IgG of a single dose rozanolixizumab or placebo.

Group	Value	95% CI
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)	-46.73	± 14.76
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)	NA	± NA
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)	-42.14	± 13.31
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)	NA	± NA
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)	-44.03	± 8.711
Cohort 3: Syringe Driver- PBO (>=50 kg)	NA	± NA
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)	-42.90	± 10.67
Cohort 4: Manual Push- PBO (>=50 kg)	NA	± NA

Time to Minimum IgG Level (Tmin) of a Single Dose Rozanolixizumab or Placebo Secondary · 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

tmin was the time to minimum IgG level of a single dose rozanolixizumab or placebo.

Group	Value	95% CI
Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)	12.08	8.98 – 42.0
Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)	NA	6.08 – 9.16
Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)	11.07	6.11 – 15.1
Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)	NA	4.00 – 42.1
Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)	9.012	5.97 – 12.1
Cohort 3: Syringe Driver- PBO (>=50 kg)	NA	5.96 – 15.1
Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)	10.55	4.00 – 15.0
Cohort 4: Manual Push- PBO (>=50 kg)	NA	2.00 – 8.95

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of dosing (Day 1) to End of Safety Follow-Up (up to Day 57). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg)

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg)

Serious: 0/2 (0%)

Deaths: 0/2

Cohort 2: Manual Push- RLZ Dose 2 (>=35 kg to <50 kg)

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 2: Manual Push- PBO (>=35 kg to <50 kg)

Serious: 0/2 (0%)

Deaths: 0/2

Cohort 3: Syringe Driver- RLZ Dose 1 (>=50 kg)

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 3: Syringe Driver- PBO (>=50 kg)

Serious: 0/2 (0%)

Deaths: 0/2

Cohort 4: Manual Push- RLZ Dose 1 (>=50 kg)

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 4: Manual Push- PBO (>=50 kg)

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (26 terms — click to expand)

Reaction	System	Cohort 1: Syringe Driver- …	Cohort 1: Syringe Driver- …	Cohort 2: Manual Push- RLZ…	Cohort 2: Manual Push- PBO…	Cohort 3: Syringe Driver- …	Cohort 3: Syringe Driver- …	Cohort 4: Manual Push- RLZ…	Cohort 4: Manual Push- PBO…
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Infusion site erythema	General disorders	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Infusion site pain	General disorders	—	—	—	—	—	—	—	—
Infusion site swelling	General disorders	—	—	—	—	—	—	—	—
Infusion site pruritus	General disorders	—	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Gingival bleeding	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Hypoaesthesia oral	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Infusion site bruising	General disorders	—	—	—	—	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Nerve injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Occult blood positive	Investigations	—	—	—	—	—	—	—	—
Respiratory rate decreased	Investigations	—	—	—	—	—	—	—	—
Vaginal haemorrhage	Reproductive system and breast disorders	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT04828343 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Targeting the Neonatal Fc Receptor in Autoimmune Diseases: Pipeline and Progress.
Gjølberg TT, Mester S, Calamera G, Telstad JS, et al · · 2025 · cited 10× · PMID 40156757 · DOI 10.1007/s40259-025-00708-2

Verify or expand the search:

Other trials of rozanolixizumab

Trials testing the same drug.

NCT06540144 — An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalize · Phase 3 · enrolling by invitation
NCT06149559 — A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis · Phase 2, PHASE3 · recruiting
NCT05643794 — A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With S · Phase 2 · completed

Other recruiting trials for Healthy Study Participants

Currently open trials in the same condition.

NCT06970301 — A Study to Assess the Safety and Tolerability, and Pharmacokinetics of UCB0022 in Healthy Caucasian, Japanese, and Chine · Phase 1 · recruiting

Other UCB Biopharma SRL trials

Trials by the same sponsor.

NCT07465289 — A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gr · Phase 3 · not yet recruiting
NCT07463521 — A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis · Phase 3 · not yet recruiting
NCT07277660 — A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Stu · Phase 2 · recruiting
NCT07290036 — A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adu · Phase 1 · recruiting
NCT07286682 — A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04828343 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UCB Biopharma SRL
Last refreshed: 7 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04828343.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04828343

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of rozanolixizumab

Other recruiting trials for Healthy Study Participants

Other UCB Biopharma SRL trials

Verify against primary sources