* MAD Study: K-757 and K-833 in healthy volunteers (K-757 P003-02)
Research type
Research Study
Full title
A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Combination K-757 and K-833 in Healthy Volunteers.
IRAS ID
1005721
Contact name
Brett Lauring
Contact email
Sponsor organisation
Kallyope, Inc.
Eudract number
2022-001578-78
Clinicaltrials.gov Identifier
Research summary
K-757 and K-833 are two investigational compounds being developed by Kallyope, Inc. for the potential treatment of weight loss and Type II Diabetes Mellitus. Current pharmacotherapies for weight loss with similar mechanism of action require injections whereas these two compounds being studied can be administered orally. K-757 and K-833 are expected to have better tolerability profile. The goal of this clinical study is to study the safety & tolerability of K-757 & K-833 when administered together because the sponsor are hoping to develop the therapy as a combination treatment.\nPreviously K-757 and K-833 have been given to human subjects in single doses but this is the first study where they will be administered in combination in multiple doses. \n3 Panels (A, B, C) of 12 subjects each (8 Active, 4 placebo) will be studied. \nParticipants will be domiciled in the CPU - Panel A for 5 days & Panel B/C for 8 days, to receive their dose & undergo assessments. Thereafter, they will will be discharged but expected to return to the unit on a daily basis to receive their doses and sample collections. They will be readmitted to the unit on Day 13 for their final dose on Day 14. All participants discharged home on Day 16. They will return to the unit on Days 17 & 18 for blood collection.\nPanel A will receive 100 mg K-833 q.d for 14 days. \nPanel B will receive a combination dose of K757 20-60mg (titration)/100 mg K-833 for 14 days. \nPanel C will receive K757 30-60 mg (titration)/K-833 100 mg Q.D for 14 days. \nDose titration & escalation for Panels B/C will depend upon ongoing oversight of safety & tolerability.\nThe primary objective is to assess the safety & tolerability of K-757 & K-833 when given in combination in multiple doses.\nThe secondary objective will be to measure the plasma concentrations of K-757 and K-833.\nExploratory objectives include measurement of hormones & other biomarkers thought to be involved in the pharmacodynamic action of K-757 and K-833.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0203
Date of REC Opinion
27 Jul 2022
REC opinion
Further Information Favourable Opinion