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Study to Access the Relative Bioavailability of Subcutaneous Dose of Nemolizumab When Administered Via Auto-Injector Versus Dual-Chamber Syringe
Phase 1 trial testing Nemolizumab in Healthy Volunteers in 192 participants. Completed in 8 December 2022.
| Lead sponsor | Galderma R&D |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 192 |
| Start date | 11 August 2022 |
| Primary completion | 11 November 2022 |
| Estimated completion | 8 December 2022 |
| Sites | 2 locations across United States |
Galderma R&D — full company profile →
Adults 18 to 65, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cmax was defined as the observed maximum serum concentration of nemolizumab. Cmax was used to measure the rate of absorption of nemolizumab.
| Group | Value | 95% CI |
|---|---|---|
| Nemolizumab With AI | 8.00 | ± 2.34 |
| Nemolizumab With DCS | 7.51 | ± 2.31 |
AUC0-inf was defined as area under the plasma concentration-time curve from time 0 to infinity according to the equation: AUC0-inf = AUClast + Clast/λz; where λz = slope of the regression line of the terminal phase of the plasma concentration versus time curve, in semi-logarithmic scale; and Clast = last measurable drug concentration.
| Group | Value | 95% CI |
|---|---|---|
| Nemolizumab With AI | 270 | ± 85.8 |
| Nemolizumab With DCS | 279 | ± 89.7 |
AUC0-4 weeks was defined as area under the concentration-time curve from time 0 to 4 weeks after study drug administration calculated with the linear trapezoidal method.
| Group | Value | 95% CI |
|---|---|---|
| Nemolizumab With AI | 157 | ± 37.9 |
| Nemolizumab With DCS | 155 | ± 39.8 |
AUC0-last was defined as area under the concentration-time curve from administration to the last observed concentration time t, calculated with the linear trapezoidal method.
| Group | Value | 95% CI |
|---|---|---|
| Nemolizumab With AI | 250 | ± 73.6 |
| Nemolizumab With DCS | 260 | ± 75.4 |
Tmax was defined as the time taken to reach the maximum observed serum concentration.
| Group | Value | 95% CI |
|---|---|---|
| Nemolizumab With AI | 4.99 | 1.00 – 21.99 |
| Nemolizumab With DCS | 5.99 | 1.00 – 22.00 |
t1/2 is defined as time required for the concentration of the drug to reach half of its original value.
| Group | Value | 95% CI |
|---|---|---|
| Nemolizumab With AI | 18.0 | ± 5.91 |
| Nemolizumab With DCS | 18.5 | ± 4.52 |
ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.
| Group | Value | 95% CI |
|---|---|---|
| Nemolizumab With AI | 6 | |
| Nemolizumab With DCS | 8 |
| Group | Value | 95% CI |
|---|---|---|
| Nemolizumab With AI | 2 | |
| Nemolizumab With DCS | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Nemolizumab With AI | 2 | |
| Nemolizumab With DCS | 8 |
Time frame: From Baseline up to Week 12. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Nemolizumab With AI | Nemolizumab With DCS |
|---|---|---|---|
| Headache | Nervous system disorders | — | — |
| Weight increased | Investigations | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Papule | Skin and subcutaneous tissue disorders | — | — |
| Viral infection | Infections and infestations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Erythema | Skin and subcutaneous tissue disorders | — | — |
| Palpitations | Cardiac disorders | — | — |
| Injection site bruising | General disorders | — | — |
| Injection site pain | General disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Skin abrasion | Injury, poisoning and procedural complications | — | — |
| Heart rate increased | Investigations | — | — |
| Weight decreased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Somnolence | Nervous system disorders | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | — | — |
| Rash papular | Skin and subcutaneous tissue disorders | — | — |
| Ear discomfort | Ear and labyrinth disorders | — | — |
| Blepharospasm | Eye disorders | — | — |
| Conjunctival hyperaemia | Eye disorders | — | — |
| Eye irritation | Eye disorders | — | — |
| Ocular discomfort | Eye disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Haemorrhoids | Gastrointestinal disorders | — | — |
| Lip pruritus | Gastrointestinal disorders | — | — |
| Palatal disorder | Gastrointestinal disorders | — | — |
| Toothache | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
Data from ClinicalTrials.gov NCT05405985 adverse events section.
This study was to compare the rate and extent of absorption of a single dose of nemolizumab administered with auto-injectors \[AI\] (test) versus dual-chamber syringes \[DCS\] (reference) under controlled conditions in healthy adult subjects.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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