Clincosm LogoSign in Get a demo

Heat Shock Protein Inhibitor- MPT0B640 for COVID-19 Infection

Sponsor
J Ints Bio (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04526717
Collaborator
(none)
0
Enrollment
1
Arm
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Indication : Treatment of Subject with COVID-19 infection Phase : Phase I Duration of Study :

12 day Sample size : at least 15 subjects Methodology : Classical 3+3 design Investigational Product : MPT0B640, 15, 30, 60, 80 and 100mg, oral suspension Study Objective

  1. Primary Objective To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of MPT0B640

  2. Secondary Objectives To evaluate the safety and tolerability of MPT0B640 during entire study period To assess the efficacy of MPT0B640 To characterize the 48 hours PK of MPT0B640

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Classical 3+3 design to determine MTD.Classical 3+3 design to determine MTD.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1, Open Label, Single Arm Study to Evaluate the Safety, Tolerability and Efficacy of MPT0B640 in Patients With COVID-19 Infection
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: MPT0B640

There is single Arm in this clinical trials.

Drug: MPT0B640
Each dose of MPT0B640 will be administrated per Cohort. (15, 30, 60, 80, 100 mg of MPT0B640)

Outcome Measures

Primary Outcome Measures

  1. MTD [28days(+/-2days)]

    MTD is defined as highest dose level in which 6 subjects have been treated with less than 2 instances of DLT. DLT assessed during the study treatment period (28 ± 2 days) refers to a medically significant event which meets one of the criteria using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Secondary Outcome Measures

  1. Viral load [Time Frame: Day 1, 3, 5, 7, 9 and 12]

    Viral load change (log10 viral load assessed by reverse transcription-qPCR)

  2. Time to clinical improvement [Time Frame: dialy up to Day 10]

    Assessed TTCI with WHO clinical progression scale by measuring clinical status daily. TTCI is defined as the time (in days) from initiation of study treatment until a decline of one category on WHO clinical progression scale which ranges from 0 (uninfected; no viral RNA detected) to 10 (death)

Other Outcome Measures

  1. Pharmacokinetic (PK) [Day 1,3 and 5.]

    Cmax

  2. Pharmacokinetic (PK) [Day 1,3 and 5.]

    Ctrough

  3. Pharmacokinetic (PK) [Day 1,3 and 5.]

    AUCτ

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Subjects must meet all inclusion criteria as listed below:

  1. Age ≥18 years at time of signing Informed Consent Form

  2. Laboratory (quantitative Polymerase Chain Reaction, qPCR) confirmed infection with 2019-nCoV.

  3. Lung involvement confirmed with chest imaging

  4. Hospitalized with a SaO2/SPO2≤94% on room air or PaO2/FiO2 ratio <300mgHg

  5. ≤7 days since illness onset

  6. Must agree not to enroll in another study of an investigational agent prior to completion of Day 12 of study.

Exclusion Criteria:

  1. Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.

  2. Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit)

  3. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination

  4. Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis

  5. Will be transferred to another hospital which is not the study site within 72 hours.

  6. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • J Ints Bio

Investigators

  • Study Director: Ethan Seah, J Ints Bio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
J Ints Bio
ClinicalTrials.gov Identifier:
NCT04526717
Other Study ID Numbers:
  • JO201901-02
First Posted:
Aug 26, 2020
Last Update Posted:
Jun 11, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Jun 11, 2021