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Autoimmune DiseasesPhase 1NCT05853835

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

A Phase 1 study testing LPX-TI641 in people with Autoimmune Diseases and Multiple Sclerosis, run by LAPIX Therapeutics Inc. at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Autoimmune Diseases, Multiple Sclerosis
What is being tested?
LPX-TI641
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesin 2 countries
Study dates
30 Oct 2023to 1 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).
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  • 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.
  • The following applies to all female volunteers with childbearing potential and female partners of male volunteers enrolled in the study.
  • Implantable progestogen-only hormone contraception associated with inhibition of ovulation.
  • 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.
  • 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.
  • 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.
  • A combination of male condoms with either cervical cap, diaphragm, or sponge with spermicide (double-barrier methods).
  • Vasectomy

Who cannot join

  • 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
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  • 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):
  • prescription medications within 14 days prior to dosing or 5 half-lives, whichever is longer;
  • over-the-counter products and natural health products (including herbal remedies homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days prior to dosing or 5 half-lives, whichever is longer, except for the occasional use of paracetamol (up to 2 g daily);
  • any prescription or over-the-counter medication or natural health products used for the treatment of irregular bowel transit (e.g,. diarrhea, constipation) within 4 weeks prior to dosing;
  • depot injection or implant of any drug within 3 months prior to dosing;
  • use of any drugs known to induce or inhibit hepatic metabolism (including St. John's Wort [hypericin]) within 14 days prior to dosing.
  • The subject has participated in another investigational study involving any investigational product within 60 days, or 5 half-lives, whichever is longer, before the dose of the study drug.
  • Pregnant or lactating women or women currently undergoing infertility treatments or women who intend to become pregnant during the time of study enrollment.
  • Involvement in the planning and conduct of the study (applies to CRO staff or staff at the study site).

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • AXIS Clinicals

    Dilworth, Minnesota, 56529

Other trials in United States

Jordan1 site

  • Triumpharma clinical research unit at Alessra Hospital

    Amman

Other trials in Jordan

About this study

Official title: 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.

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.

Read the 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.

Being tested
LPX-TI641
Medical subject headings
Autoimmune Diseases, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LPX-TI641Drug

    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).

Study groups in NCT05853835
Study groupRoleWhat they receive
Cohort-1ExperimentalFirst dose of SAD cohort (6 treatment + 2 placebo)
Receives: Drug: LPX-TI641
Cohort-2ExperimentalSecond dose of SAD cohort (6 treatment + 2 placebo)
Receives: Drug: LPX-TI641
Cohort-3ExperimentalThird dose of SAD cohort (6 treatment + 2 placebo)
Receives: Drug: LPX-TI641
Cohort-4ExperimentalFourth dose of SAD cohort (6 treatment + 2 placebo)
Receives: Drug: LPX-TI641
Cohort-5ExperimentalFifth dose of SAD cohort (6 treatment + 2 placebo)
Receives: Drug: LPX-TI641
Cohort-6ExperimentalSixth dose of SAD cohort (6 treatment + 2 placebo)
Receives: Drug: LPX-TI641
Cohort-7ExperimentalFirst dose of MAD cohort (6 treatment + 2 placebo)
Receives: Drug: LPX-TI641
Cohort 8ExperimentalSecond dose of MAD cohort (6 treatment + 2 placebo)
Receives: Drug: LPX-TI641
Cohort 9ExperimentalThird dose of MAD cohort (6 treatment + 2 placebo)
Receives: Drug: LPX-TI641

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 14 days

  2. 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.

    Measured: 21 days

Secondary outcomes (2)

  1. To evaluate the plasma pharmacokinetics after single ascending oral doses of LPX-TI641 in healthy adult volunteers.

    Measurements of PK parameters including

    • Maximum observed plasma concentration (Cmax),
    • Time to first occurrence of Cmax (Tmax),
    • Area under the plasma concentration-time curve from time 0 to the time last concentration measurement (AUC0-last)
    • Area under the plasma concentration-time curve from time 0 to 24 hr (AUC0-24)
    • Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞),
    • Percentage AUC extrapolated (%AUCextrap)
    • Terminal disposition phase half-life (t1/2z),
    • Apparent clearance after extravascular administration (CL/F),
    • Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)

    Measured: Day 1

  2. To evaluate the plasma pharmacokinetics after multiple ascending oral doses of LPXTI641 in healthy adult volunteers.

    Measuring the PK parameters such as Cmax, Tmax, AUC0-last, AUC0-24, %AUCextrap, t1/2, CL/F, Vz/F at steady state

    • Minimal observed concentration within the dosing interval (Ctrough)
    • Accumulation index (Cmax and AUC)

    Measured: Day 1 and Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start30 Oct 2023
  3. Primary completion15 Aug 2024
  4. Study completion1 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05853835
Sponsor's protocol ID
LPX641-101
Status last verified
Jun 2024
First submitted
28 Apr 2023
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LPX-TI641 in people with Autoimmune Diseases and Multiple Sclerosis, run by LAPIX Therapeutics Inc. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety and tolerability after single ascending oral doses of LPX-TI641 in healthy adult volunteers. (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05853835.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

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