First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641

NCT05853835 | Completed Phase 1 FDA Drug

• 1 other identifier: LPX641-101
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 2

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.

Conditions

Autoimmune Diseases; Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability after single ascending oral doses of LPX-TI641 in healthy adult volunteers.

  Proportion of subjects with AEs, SAEs and DLTs will be recorded.

  14 days

• To evaluate the safety and tolerability after multiple ascending oral doses of LPX-TI641 in healthy adult volunteers.

  Proportion of subjects with AEs, SAEs and DLTs will be recorded.

  21 days

Secondary Outcomes (2)

• 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

Study Arms (9)

Cohort-1

EXPERIMENTAL

First dose of SAD cohort (6 treatment + 2 placebo)

Drug: LPX-TI641

Cohort-2

EXPERIMENTAL

Second dose of SAD cohort (6 treatment + 2 placebo)

Drug: LPX-TI641

Cohort-3

EXPERIMENTAL

Third dose of SAD cohort (6 treatment + 2 placebo)

Drug: LPX-TI641

Cohort-4

EXPERIMENTAL

Fourth dose of SAD cohort (6 treatment + 2 placebo)

Drug: LPX-TI641

Cohort-5

EXPERIMENTAL

Fifth dose of SAD cohort (6 treatment + 2 placebo)

Drug: LPX-TI641

Cohort-6

EXPERIMENTAL

Sixth dose of SAD cohort (6 treatment + 2 placebo)

Drug: LPX-TI641

Cohort-7

EXPERIMENTAL

First dose of MAD cohort (6 treatment + 2 placebo)

Drug: LPX-TI641

Cohort 8

EXPERIMENTAL

Second dose of MAD cohort (6 treatment + 2 placebo)

Drug: LPX-TI641

Cohort 9

EXPERIMENTAL

Third dose of MAD cohort (6 treatment + 2 placebo)

Drug: LPX-TI641

Interventions

LPX-TI641 DRUG

LAPIX Therapeutics Inc (LAPIX) has developed LPX-TI641, a small molecule for immune tolerance restoration/induction that is an orally bioavailable Tim family agonist (Tim-3 and Tim-4).

Cohort 8; Cohort 9; Cohort-1; Cohort-2; Cohort-3; Cohort-4; Cohort-5; Cohort-6; Cohort-7

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• i. Implantable progestogen-only hormone contraception associated with inhibition of ovulation.
• ii. Intrauterine device. iii. Intrauterine hormone-releasing system. iv. Bilateral tubal occlusion. v. Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: 1) Oral 2) Intravaginal 3)Transdermal 4) Injectable vi. Progestogen-only hormone contraception (oral or injectable) is associated with inhibition of ovulation.
• vii. Vasectomized partner viii. Sexual abstinence -this is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated about the duration of the study and the preferred and usual lifestyle of the participant.
• b. The following applies to all male subjects in the study: i. Sexual abstinence- this is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated for the duration of the study and the preferred and usual lifestyle of the participant.
• ii. A combination of male condoms with either cervical cap, diaphragm, or sponge with spermicide (double-barrier methods).
• iii. Vasectomy

You may not qualify if:

• Any known history of malignancy
• Any known history of asthma
• COVID-19:
• 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)
• Clinically significant ECG abnormalities (QTcF \>450 ms for males and QTcF \>470 ms for females).
• History of or current compulsive abuse of alcohol or positive test for alcohol at screening or Day 0 of Visit 1
• History of or current use of or positive test at screening or Day 0 of Visit 1 for drugs such as marijuana, cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives.
• Consumption of any beverages or food containing alcohol or drugs such as marijuana, cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives from screening until donating the last sample of the study
• Use of medications for the timeframes specified below, except for medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):

Sponsors & Collaborators

• LAPIX Therapeutics Inc.: lead

Study Sites (2)

AXIS Clinicals

Dilworth, Minnesota, 56529, United States

Location

Triumpharma clinical research unit at Alessra Hospital

Amman, Jordan

Location

MeSH Terms

Conditions

Autoimmune Diseases; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases

Study Officials

• Mustafa Mahmoud Shennak, MD

  Triumpharma

  PRINCIPAL INVESTIGATOR

• John Mickelson, DO

  AXIS Clinicals, Dilworth, Minnesota USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigational drug blind will be maintained through a randomization schedule held by the dispensing pharmacist. The investigational drug blind shall not be broken by the site Investigator unless information concerning the investigational drug is necessary for the medical treatment of the subject. All study assessments and causality will be performed, if possible, prior to unblinding.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 11, 2023
• Study Start: October 30, 2023
• Primary Completion: August 15, 2024
• Study Completion: November 1, 2024
• Last Updated: January 23, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1); US (1)