NCT03949426

Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects

A First-in-Human, Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Dose Study in Healthy Participants to Evaluate the Safety, Tolerability and Pharmacokinetics of KPG-818

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Kangpu Biopharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1 study to investigate the safety, tolerability and pharmacokinetics (PK) of KPG-818 in healthy male and female participants and the effect of food on the PK of KPG-818. The study will assist in identifying appropriate, well tolerated doses that can be administered in subsequent studies in healthy participants and participants with systemic lupus erythematosus (SLE).

Detailed description

A total of 40 subjects will be evaluated with 30 subjects randomized to receive active drug and 10 subjects randomized to receive placebo in a double-blind fashion (8 subjects in each dose cohort, 6 subjects randomized to active drug and 2 subjects randomized to placebo). Five dose levels (2, 5, 10, 20 and 30 mg) are planned to be evaluated.The study will be double blinded with regard to treatment (KPG-818 or placebo) at each dose level. KPG-818 and placebo will be matched for formulation, appearance and number of capsules. Safety assessments will be performed throughout the study including physical examinations, vital signs, clinical laboratory tests, 12 lead electrocardiograms and monitoring of adverse events. Pharmacokinetic blood and urine samples will be collected up to 72 hours after dosing. A post-treatment follow-up visit will be performed within 10 days of the last dose of study treatment.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	KPG-818	KPG-818 Capsules (1 mg, 5 mg and 20 mg) for oral administration is the drug substance powder filled in capsule (PIC) dosage form. KPG-818 Capsules and placebo capsules are packaged in HDPE bottle capped with HDPE cap.

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-09-29
• Completion: 2019-09-29
• First posted: 2019-05-14
• Last updated: 2020-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study