Huashan Hospital, Fudan University
Shanghai, 200040, China
NCT Number: NCT04390568
The primary objective of this trial is to investigate pharmacokinetics, including dose proportionality, following single intravenous and subcutaneous doses of spesolimab in healthy Chinese subjects.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Shanghai, 200040, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Spesolimap
Other names: BI 655130
Time frame: Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.
Area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
The time frames differed slightly between intravenous (IV) and subcutaneous (SC) administration. The prefix 'IV' indicates when IV was measured only. The prefix 'SC' indicates when SC was measured only. No prefix means that measurement time points were identical for IV and SC administration.
Time frame: Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.
Maximum measured concentration of the Spesolimap in plasma (Cmax) The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-8).
The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
The time frames differed slightly between intravenous (IV) and subcutaneous (SC) administration. The prefix 'IV' indicates when IV was measured only. The prefix 'SC' indicates when SC was measured only. No prefix means that measurement time points were identical for IV and SC administration.
Time frame: Frome day of drug administration until 16 weeks thereafter, up to 16 weeks.
Number of participants with treatment-emergent AEs.
All AEs occurring between first drug administration until 16 weeks thereafter were assigned to the randomised treatment.
Time frame: Frome day of drug administration until 16 weeks thereafter, up to 16 weeks.
Number of participants with drug-related AEs.
All AEs occurring between first drug administration until 16 weeks thereafter were assigned to the randomised treatment.
Boehringer Ingelheim
Industry
An Open-label Phase I Trial to Assess Pharmacokinetics and Safety of Single Subcutaneous Doses and Single Intravenous Doses of BI 655130 in Healthy Chinese Male and Female Subjects (Single Doses, Open-label Study in Parallel-group Design).
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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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