Clinical trial NCT03880487: A Single and Multiple Ascending Dose Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of KP-1199
Official title: A Randomized, Placebo- and Active-Controlled, Double-Blind, Single and Multiple Ascending Dose Study in Healthy Adults to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KP-1199
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Analgesia
Keywords: Phase I, Healthy Adult Participants
Lead sponsor: Kalyra Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
name: PRA Health Sciences
First posted: 2019-03-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase I, randomized, placebo and active-controlled, double blind, single and multiple ascending dose study in healthy adults to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of KP-1199


Eligibility criteria: Inclusion Criteria:

* Healthy Adult 18-45 years of age at time of screening, inclusive.
* Have a body mass index (BMI) between 18.0 and ≤32 kg/m2, inclusive, and a weight of ≥50 kg at screening.
* Be determined to be healthy on the basis of a pre-study physical examination, medical history review, vital sign measurements, and the results of laboratory tests.
* For both male and females: using acceptable method of birth control
* If Female: not-pregnant or not breast feeding and not planning on becoming pregnant
* All prescribed medication must have been stopped at least 14 days prior to admission to the clinical research site. An exception is made for hormonal contraceptives, which may be used throughout the study.
* All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research site.
* Must be adequately informed and understand the nature and risks of the study and must provide written informed consent prior to enrollment at screening.

Exclusion Criteria:

* Subjects who participate in one part of the study are not eligible to participate in subsequent parts of the study.
* Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
* Males with female partners who are planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
* History or evidence of significant clinical or psychiatric disorder, condition, or disease that, in the opinion of the Investigator would pose an unacceptable risk to the subject safety or interfere with the study evaluations, procedures, or completion of the study.
* Documented congenital QT syndrome, and/or corrected QT interval (Fridericia correction; QTcF) at screening or first admission \> 450 ms.
* Positive screening test for hepatitis B surface antigen, anti-hepatitis C virus antibodies or anti-human immunodeficiency virus 1 and 2 antibodies.
* History of drug allergy diagnosed by a physician.
* Use of tobacco within 30 days prior to the first study drug administration.
* History of alcohol consumption exceeding 2 standard drinks per day on average.
* Routine or chronic use of more than 0.5 grams of acetaminophen daily.
* History of donation of more than 450 mL of blood within 60 days prior to dosing in the clinical research site or planned donation before 30 days has elapsed since intake of study drug.
* Plasma or platelet donation within 7 days of dosing
* Use of any investigational drug or device within 30 days of the first dose of study.

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events
timeFrame: Part 1: From Day 1 through Day 6, Part 2: From Day 1 through Day 11, Part 3: From Day 1 through Day 12
Secondary outcomes:
measure: Pharmacokinetic Profile of KP-1199 to measure plasma concentration of KP-1199
timeFrame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
measure: Pharmacokinetic Profile of KP-1199 to measure Time to Maximum plasma concentration of KP-1199
timeFrame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
measure: Pharmacokinetic Profile of KP-1199 to measure area under curve plasma concentration of KP-1199
timeFrame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
measure: Pharmacokinetic Profile of KP-1199 to measure plasma terminal half-life concentration of KP-1199
timeFrame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
measure: Pharmacokinetic Profile of KP-1199 to measure the trough plasma concentration of KP-1199
timeFrame: Part 1: Day 1 (pre-dose through 4 hours after dose administration), Part 2: (pre-dose through Day 8), Part 3: (pre-dose through Day 7)
measure: Pharmacodynamic Effects of KP-1199 using Cold Pressor Test to measure pain threshold
timeFrame: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
measure: Pharmacodynamic Effects of KP-1199 using Cold Pressor Test to measure pain tolerance
timeFrame: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
measure: Pharmacodynamic Effects of KP-1199 using Cold Pressor Test
timeFrame: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
measure: Pharmacodynamic Effects of KP-1199 using Ultraviolet Burn Model (UVB)
timeFrame: Part 3: Day 1, Day 3, Day 5 and Day 7 (pre-dose through 6 hours after dose administration)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
Study officials:
affiliation: Kalyra Pharmaceuticals, Inc.
name: Kevin Bunker, PhD
role: STUDY_DIRECTOR
References: