Heat Shock Protein Inhibitor- MPT0B640 for COVID-19 Infection

NCT04526717 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: JO201901-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. 1.Primary Objective To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of MPT0B640
2. 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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• MTD

  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.

  28days(+/-2days)

Secondary Outcomes (2)

• Viral load

  Time Frame: Day 1, 3, 5, 7, 9 and 12

• Time to clinical improvement

  Time Frame: dialy up to Day 10

Other Outcomes (3)

• Pharmacokinetic (PK)

  Day 1,3 and 5.

• Pharmacokinetic (PK)

  Day 1,3 and 5.

• Pharmacokinetic (PK)

  Day 1,3 and 5.

Study Arms (1)

MPT0B640

OTHER

There is single Arm in this clinical trials.

Drug: MPT0B640

Interventions

MPT0B640 DRUG

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

MPT0B640

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years at time of signing Informed Consent Form
• Laboratory (quantitative Polymerase Chain Reaction, qPCR) confirmed infection with 2019-nCoV.
• Lung involvement confirmed with chest imaging
• Hospitalized with a SaO2/SPO2≤94% on room air or PaO2/FiO2 ratio \<300mgHg
• ≤7 days since illness onset
• Must agree not to enroll in another study of an investigational agent prior to completion of Day 12 of study.

You may not qualify if:

• 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.
• Severe liver disease (e.g. Child Pugh score ≥ C, AST\>5 times upper limit)
• Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
• 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
• Will be transferred to another hospital which is not the study site within 72 hours.
• 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.

Sponsors & Collaborators

• J Ints Bio: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ethan Seah

  J Ints Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Classical 3+3 design to determine MTD.

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 26, 2020
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share