A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 in Adult Subjects with Short Bowel Syndrome-associated Intestinal Failure (SBS-IF) (DOLPHINS-2)

Conditions

Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)

Brief summary

Primary endpoints to assessment of safety and tolerability of HM15912 after multiple subcutaneous (SC) doses for 24 weeks: • Incidence of adverse events (AEs) • Incidence of injection site reactions • Incidence of clinical laboratory abnormalities • Clinically significant findings on physical examination • Changes from baseline in vital signs and 12-lead electrocardiogram (ECG) parameters, Primary endpoints to assessment of the pharmacokinetic (PK) profile of HM15912: • Maximum serum concentration (Cmax) • Time to maximum serum concentration (tmax) • Elimination half-life (t1/2) • Volume of distribution (Vd/F) • Clearance (CL/F) • Area under the concentration-time curve from time zero to the last observable concentration (AUClast), AUC from time zero over the dosing interval at the 1st and 6th dosing, respectively (AUCtau and AUCtau,ss), and AUC extrapolated to infinity

Detailed description

Change in weekly parenteral nutrition/intravenous fluid (PN/IV) volume from baseline to Week 25 Note: The baseline PN/IV volume (L/week) is the average of actual PN/IV volume received during the last 2 weeks of the Stabilization period.

Related papers

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Interventions

DRUGSolution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary endpoints to assessment of safety and tolerability of HM15912 after multiple subcutaneous (SC) doses for 24 weeks: • Incidence of adverse events (AEs) • Incidence of injection site reactions • Incidence of clinical laboratory abnormalities • Clinically significant findings on physical examination • Changes from baseline in vital signs and 12-lead electrocardiogram (ECG) parameters, Primary endpoints to assessment of the pharmacokinetic (PK) profile of HM15912: • Maximum serum concentration (Cmax) • Time to maximum serum concentration (tmax) • Elimination half-life (t1/2) • Volume of distribution (Vd/F) • Clearance (CL/F) • Area under the concentration-time curve from time zero to the last observable concentration (AUClast), AUC from time zero over the dosing interval at the 1st and 6th dosing, respectively (AUCtau and AUCtau,ss), and AUC extrapolated to infinity	—

Measure

Time frame

Primary endpoints to assessment of safety and tolerability of HM15912 after multiple subcutaneous (SC) doses for 24 weeks: • Incidence of adverse events (AEs) • Incidence of injection site reactions • Incidence of clinical laboratory abnormalities • Clinically significant findings on physical examination • Changes from baseline in vital signs and 12-lead electrocardiogram (ECG) parameters, Primary endpoints to assessment of the pharmacokinetic (PK) profile of HM15912: • Maximum serum concentration (Cmax) • Time to maximum serum concentration (tmax) • Elimination half-life (t1/2) • Volume of distribution (Vd/F) • Clearance (CL/F) • Area under the concentration-time curve from time zero to the last observable concentration (AUClast), AUC from time zero over the dosing interval at the 1st and 6th dosing, respectively (AUCtau and AUCtau,ss), and AUC extrapolated to infinity

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Secondary

Measure	Time frame
Change in weekly parenteral nutrition/intravenous fluid (PN/IV) volume from baseline to Week 25 Note: The baseline PN/IV volume (L/week) is the average of actual PN/IV volume received during the last 2 weeks of the Stabilization period.	—

Countries

Belgium, Denmark, France, Germany, Poland

Outcome results

None listed