A Phase I First in Human, Randomized, Double-blind, Placebo- Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability and Pharmacokinetics of LPX-TI641 After Single and Multiple Oral Doses.
Overview
- Phase
- Phase 1
- Intervention
- LPX-TI641
- Conditions
- Autoimmune Diseases
- Sponsor
- LAPIX Therapeutics Inc.
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- To evaluate the safety and tolerability after single ascending oral doses of LPX-TI641 in healthy adult volunteers.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
A Phase I First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability, and Pharmacokinetics after Single and Multiple Oral Dose of LPX-TI641.
Detailed Description
This is a first-in-human, multi center, randomized, double-blinded, single and multiple ascending doses (SAD and MAD) Phase I study in healthy adult volunteers (HV). The SAD cohorts will consist of six cohorts of eight participants (6 randomized to treatment + 2 randomized to placebo) in each cohort (Total 48 HV). Additional cohorts may be added. The MAD cohorts will consist of 3 cohorts of eight participants (6 randomized to treatment + 2 randomized to placebo) in each cohort (Total 24 HV). The subjects in MAD cohorts will be dosed once daily for 7 consecutive days. Additional cohorts may be added. Each entire cohort of 8 HV subjects will be enrolled at the same site.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers
- •Subject has signed an Informed Consent Form (ICF) prior to any study-specific procedures being performed
- •Healthy volunteers (HV) with no known acute or chronic medical conditions (respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, endocrine, etc.) at the time of enrollment.
- •Healthy volunteers (HV) with dermatological conditions are allowed if they are not receiving systemic treatments for their dermatological condition.
- •All male and non-pregnant females aged 18-55 years old irrespective of their race and ethnicity.
- •Body Mass Index (BMI) 18.0-30.0 kg/m2, inclusive at screening.
- •Clinical laboratory evaluations performed at screening, are within acceptable normal reference ranges (Grade 1 abnormalities may be acceptable if deemed necessary by the investigator. Grade 2 or higher would be exclusionary).
- •Subjects who are willing and able to adhere to study protocol requirements including but not limited to scheduled outpatient visits, inpatient hospital stay, laboratory tests, and 12-lead ECG.
- •Contraception - All subjects (male and female) must agree to use any two of the highly effective contraception methods listed below. This criterion must be followed from the time of the first dose of study medication for 6 weeks after the last dose in females and for 90 days after the last dose for males.
- •a. The following applies to all female volunteers with childbearing potential and female partners of male volunteers enrolled in the study.
Exclusion Criteria
- •Healthy volunteers
- •Any known history of malignancy
- •Any known history of asthma
- •The subject has COVID-19 positive status (confirmed by clinical signs and symptoms and a positive SARS-CoV-2 NAAT result COVID test) at any time during the screening period.
- •OR has had recent COVID-19 vaccination including a booster dose in the past 30 days
- •OR has received anti-viral therapy intended to prevent COVID-19 such as nelmetavir/ritonavir, remdesivir, molnupiravir, interferons, Anti-SARS-CoV-2 monoclonal antibodies, IVIG SARS-CoV-2, COVID-19 Convalescent plasma, etc. within the past 30 days
- •Subject with positive results for HBsAg (hepatitis B surface antigens) and/or HBcAb (Hepatitis B core antibodies) and/or HCV Ab (hepatitis C antibodies), and/or HIV Ab (human immunodeficiency virus antibodies).
- •Blood loss of \>250 mL or donated blood within 56 days or donated plasma within 7 days of screening.
- •Recent vaccination with live attenuated vaccines such as influenza, MMR, Herpes zoster, varicella, yellow fever, Rotavirus vaccine, etc., or inactivated vaccines such as Hepatitis A, Rabies vaccine, etc. in the past 30 days.
- •Abnormal amylase levels (Grade 2 or greater)
Arms & Interventions
Cohort-7
First dose of MAD cohort (6 treatment + 2 placebo)
Intervention: LPX-TI641
Cohort-1
First dose of SAD cohort (6 treatment + 2 placebo)
Intervention: LPX-TI641
Cohort-2
Second dose of SAD cohort (6 treatment + 2 placebo)
Intervention: LPX-TI641
Cohort-3
Third dose of SAD cohort (6 treatment + 2 placebo)
Intervention: LPX-TI641
Cohort-4
Fourth dose of SAD cohort (6 treatment + 2 placebo)
Intervention: LPX-TI641
Cohort-5
Fifth dose of SAD cohort (6 treatment + 2 placebo)
Intervention: LPX-TI641
Cohort-6
Sixth dose of SAD cohort (6 treatment + 2 placebo)
Intervention: LPX-TI641
Cohort 8
Second dose of MAD cohort (6 treatment + 2 placebo)
Intervention: LPX-TI641
Cohort 9
Third dose of MAD cohort (6 treatment + 2 placebo)
Intervention: LPX-TI641
Outcomes
Primary Outcomes
To evaluate the safety and tolerability after single ascending oral doses of LPX-TI641 in healthy adult volunteers.
Time Frame: 14 days
Proportion of subjects with AEs, SAEs and DLTs will be recorded.
To evaluate the safety and tolerability after multiple ascending oral doses of LPX-TI641 in healthy adult volunteers.
Time Frame: 21 days
Proportion of subjects with AEs, SAEs and DLTs will be recorded.
Secondary Outcomes
- To evaluate the plasma pharmacokinetics after single ascending oral doses of LPX-TI641 in healthy adult volunteers.(Day 1)
- To evaluate the plasma pharmacokinetics after multiple ascending oral doses of LPXTI641 in healthy adult volunteers.(Day 1 and Day 7)