Last reviewed · How we verify
A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants.
Phase 1 trial testing SHP643 in Healthy Volunteers in 190 participants. Completed in 13 November 2019.
| Lead sponsor | Shire |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 190 |
| Start date | 14 May 2019 |
| Primary completion | 13 November 2019 |
| Estimated completion | 13 November 2019 |
| Sites | 1 location across United States |
Shire — full company profile →
Adults 18 to 55, 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.
AUC(0-last) of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
| Group | Value | 95% CI |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | 348.9 | ± 33.4 |
| SHP643 Autoinjector (AI) | 376.5 | ± 41.3 |
AUC(0-infinity) of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
| Group | Value | 95% CI |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | 352.5 | ± 32.9 |
| SHP643 Autoinjector (AI) | 380.3 | ± 40.8 |
Cmax is the maximum observed plasma concentration of SHP643 in Plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
| Group | Value | 95% CI |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | 15.86 | ± 40.6 |
| SHP643 Autoinjector (AI) | 18.35 | ± 48.0 |
Tmax of of SHP643 in plasma was reported.
| Group | Value | 95% CI |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | 4.00 | 3.00 – 19.97 |
| SHP643 Autoinjector (AI) | 4.00 | 2.00 – 6.92 |
t1/2 of of SHP643 in plasma was reported.
| Group | Value | 95% CI |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | 13.76 | 9.70 – 20.5 |
| SHP643 Autoinjector (AI) | 13.20 | 8.21 – 40.1 |
CL/F of of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
| Group | Value | 95% CI |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | 0.8511 | ± 32.9 |
| SHP643 Autoinjector (AI) | 0.7888 | ± 40.8 |
Vdz/F of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
| Group | Value | 95% CI |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | 16.79 | ± 31.6 |
| SHP643 Autoinjector (AI) | 15.37 | ± 42.7 |
Lambda z of SHP643 in Plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
| Group | Value | 95% CI |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | 0.05070 | ± 15.1 |
| SHP643 Autoinjector (AI) | 0.05132 | ± 22.1 |
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the investigational product (IP) or medicinal product. A treatment-emergent AE (TEAE) was defined as any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the IP or medicinal product.
| Group | Value | 95% CI |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | 19 | |
| SHP643 Autoinjector (AI) | 30 |
Plasma samples were analyzed for presence of antidrug antibodies to SHP643. Participants who developed positive results for SHP643 antibodies were reported.
| Group | Value | 95% CI |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | 1 | |
| SHP643 Autoinjector (AI) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | 0 | |
| SHP643 Autoinjector (AI) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | 1 | |
| SHP643 Autoinjector (AI) | 0 |
| Group | Value | 95% CI |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | 0 | |
| SHP643 Autoinjector (AI) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | 0 | |
| SHP643 Autoinjector (AI) | 1 |
Time frame: From start of study drug administration up to Day 112 (End of Study/Early Termination [EOS/ET]). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | SHP643 Prefilled Syringe (… | SHP643 Autoinjector (AI) |
|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — | — |
| Appendicitis | Infections and infestations | — | — |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | — | — |
| Nephrolithiasis | Renal and urinary disorders | — | — |
| Abortion induced | Surgical and medical procedures | — | — |
| Reaction | System | SHP643 Prefilled Syringe (… | SHP643 Autoinjector (AI) |
|---|---|---|---|
| Injection site haemorrhage | General disorders | — | — |
Most-reported serious reactions: Anaemia, Appendicitis, Abortion spontaneous, Nephrolithiasis, Abortion induced.
Data from ClinicalTrials.gov NCT03918239 adverse events section.
The purpose of this study is to evaluate bioavailability of lanadelumab (SHP643) following a single, 2 milliliter (mL) subcutaneous (SC) dose of 300 milligrams (mg) delivered by prefilled syringe (PFS) or auto injector (AI) in healthy adult participants.
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
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/NCT03918239.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing