Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03949426|
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : November 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: KPG-818||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel and Sequential|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||The study is double-blind with regard to treatment (KPG-818 or placebo) at each dose level. Any clinical staff involved in the preparation or administration of the study intervention and who are unblinded will take no further part in the study. will remain blinded during the study conduct, unless otherwise required based on study findings. The pharmacokineticist will be unblinded to perform the final PK analyses after all participants have completed the study.|
|Official Title:||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|
|Actual Study Start Date :||May 1, 2019|
|Actual Primary Completion Date :||September 29, 2019|
|Actual Study Completion Date :||September 29, 2019|
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.
Other Name: Matching placebo
No Intervention: Placebo
- Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 72 hrs post-dose ]Number of Treatment-Emergent Adverse Events(TEAE)
- Maximum Tolerated Dose [Safety and Tolerability] [ Time Frame: Up to 72 hrs post-dose ]If dose escalation is stopped based on available safety data, the current dose level will be considered as the Minimum intolerable dose (MID). The dose just below the MID will be regarded as the MTD. If the dose escalation is stopped due to reaching exposure limit without dose limiting safety findings, the MTD cannot be determined.
- Blood KPG-818 concentrations [ Time Frame: Up to 72 hrs post-dose ]Blood samples for analysis of KPG-818 and KPG-818H will be collected at pre-dose (within 30 minutes) and 0.5, 1, 2, 4, 6, 10, 12 and 18 hours post-dose on day 1; 24 and 36 hours post-dose on day 2; 48 hours post-dose on day 3 and 72 hours post-dose on day 4.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949426
|United States, California|
|California Clinical Trials Medical Group|
|Glendale, California, United States, 91206|
|Principal Investigator:||Esther Yoon, MD||California Clinical Trials|