Phase One Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of MSP008-22 in Healthy Adult Volunteers

NCT05532293 | Completed Phase 1

• 2 other identifiers: Clinexel-GBL-003CTRI/2022/08/045056
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase I clinical study of MSP008-22, the Investigational Medicinal Product (IMP). The current study is designed to evaluate the safety and tolerability and pharmacokinetics of single and multiple oral doses of the IMP (MSP008-22) in healthy volunteers.

Conditions

COVID-19

Keywords

Single Ascending Dose; Phase 1; Multiple Ascending Dose; randomised, double blind; MSP008-22; healthy volunteers; COVID-19; safety; tolerability; pharmacokinetics

Outcome Measures

Primary Outcomes (7)

• Number of participants with adverse events [Time Frame- ]

  To assess safety \& tolerability of MSP008-22 in Human

  30 days post last dose for each cohort

• Incidence of serious adverse events (SAEs) by relation to the IMP (related/not related)

  To assess safety \& tolerability of MSP008-22 in Human

  30 days post last dose for each cohort

• Percentage of volunteers who experience at least 1 Treatment Emergent Adverse Event (TEAE)

  To assess safety \& tolerability of MSP008-22 in Human

  30 days post last dose for each cohort

• Percentage of volunteers who discontinue due to an Adverse Event (AE).

  To assess safety \& tolerability of MSP008-22 in Human

  30 days post last dose for each cohort

• Percentage of volunteers who meet the markedly abnormal criteria for safety laboratory tests at least once post dose.

  To assess safety MSP008-22 in Human

  7 days post last dose for each cohort

• Percentage of volunteers who meet the markedly abnormal criteria for vital sign measurements at least once post dose

  To assess safety MSP008-22 in Human

  7 days post last dose for each cohort

• Percentage of volunteers who meet the markedly abnormal criteria for safety electrocardiogram (ECG) parameters at least once post dose.

  To assess safety MSP008-22 in Human

  7 days post last dose for each cohort

Secondary Outcomes (10)

• Plasma Cmax

  post-dose in Single ascending Dose trial & post dose on days 1 & 7 in Multiple ascending dose part of the trial

• Plasma Tmax

  post-dose in Single ascending Dose trial & post dose on days 1 & 7 in Multiple ascending dose part of the trial

• Plasma AUC0-t

  Single ascending Dose

• Plasma AUC0-inf

  Single ascending Dose

• Plasma AUC0-tau

  post dose on days 1 & 7 in Multiple ascending dose part of the trial

Study Arms (2)

MSP008-22

EXPERIMENTAL

MSP008-22 is a New Chemical Entity (NCE) that has demonstrated positive outcomes during in vitro and in vivo studies for COVID19. Formulated as tablets intended for oral dosing to trial participants.

Drug: MSP008-22

Placebo

PLACEBO COMPARATOR

placebo will be identical in smell, taste, and appearance to the tablets of MSP008-22

Other: Placebo

Interventions

MSP008-22 DRUG

MSP008-22 is a small molecule with demonstrated anticancer activity in-vitro \& in vivo studies. As several anticancer drugs are also good antiviral drugs, it was anticipated that MSP008-22 can also be a promising anti-COVID drug. Accordingly, in vitro assay studies and in an in vivo study in golden Syrian hamster were conducted where MSP008-22 has shown good anti-SARSCoV2 effects.MSP008-22.

MSP008-22

Placebo OTHER

Placebo tablets identical in appearance, taste and smell to the tablets of MSP008-22

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Should be healthy adult volunteer in the age range of 18-50 years old (both inclusive).
• Should be healthy adult volunteers, with a BMI 18-30 kg/m2 (both inclusive).
• Volunteer is able to read the volunteer information sheet, to understand information about the study and willing to sign the informed consent voluntarily.
• Healthy as determined by pre-study medical history, physical examination, vital signs, haematology, chemistry parameters, pulse rate and/or blood pressure, and ECG within the reference range, or showing no clinically relevant deviations, as judged by the Investigator.
• Negative tests for Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) and human immunodeficiency virus (HIV)-l and HIV -2 antibody at screening.
• Clinical laboratory test results clinically acceptable at screening and admission.
• Negative screen for alcohol and drugs of abuse at screening and admission.
• Non-smokers or ex-smokers (must have ceased smoking \>12 months prior screening visit). If a former smoker, reason for stopping smoking to be investigated.
• The volunteer must agree to comply with the drawing of blood samples for the PK assessments.
• The volunteer is willing and able to comply with all testing and requirements defined in the protocol.
• The volunteer is willing and able to remain at the study site for the duration of the confinement period as per the protocol requirements or if exceeded, on Investigator's discretion, if exceeded and return for the outpatient visit.
• If female:
• Woman with no childbearing potential by reason of surgery or at least 1-year post-menopause (Le., 12 months post last menstrual period), or menopause confirmed by follicle-stimulating hormone (FSH) testing;
• If of childbearing potential, using an effective nonhormonal method of contraception· (intrauterine device or intrauterine system; condom or occlusive cap \[diaphragm or cervical or vault caps\] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he is the sole partner of that volunteer) for all the duration of the study and up to one month after the last Investigational medicinal product (IMP) administration;
• Negative serum pregnancy test at screening and negative urine pregnancy test on admission of each treatment period (women of childbearing potential only);

You may not qualify if:

• Volunteers meeting any of the following criteria will be excluded from this clinical study:
• The volunteer has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the Investigator.
• The volunteer has had a clinically significant illness or conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs, within 30 days of Check-in for the study.
• The volunteer has a clinically relevant history or presence of significant respiratory, neurological, hepatic, renal, endocrine, cardiovascular, neurological, gastrointestinal, pulmonary, haematological, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue, lymphatic or metabolic disease or disorders.
• The volunteer has a significant infection or known inflammatory process on screening or admission.
• The volunteer has acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission.
• The volunteer has a clinically significant surgical history
• The volunteer has used any prescription medication within 14 days of dosing or over-the-counter (OTC) medication within 48 h of dosing or intends to use any prescription medication or OTC medication during the study that may interfere with the evaluation of study medication.
• The volunteer has had used medicines within 2 weeks of admission that may affect the safety or other study assessments, in the investigator's opinion
• The volunteer has consumed alcohol, caffeine or xanthine-containing products 48 h before dosing or intends to use any of these products during the study.
• The volunteer has consumed grapefruit, grapefruit juice, or grapefruit-containing products 7 days before dosing or intends to use any of these products during the study.
• The volunteer has a history of substance abuse or a positive ethanol breath test, urine cotinine, or urine drug screen at screening or at check-in.
• The volunteer has a positive HIV test at the Screening Visit.
• The volunteer has received an investigational drug within 30 days of Check-in.
• Use of any investigational drug within 30 days, or 5 half-lives, whichever is longer, prior to the planned first drug administration.

Sponsors & Collaborators

• Godavari Biorefineries Limited: lead

Study Sites (2)

K. J. Somaiya Hospital & Research Centre, Somaiya Ayurvihar Complex, Eastern Express Highway, Sion East

Mumbai, Maharashtra, 400022, India

Location

Ashirwad Hospital & Research Centre, Maratha Section, Near Jijamata Udyan, Ulhasnagar, Maharashtra, India

Ulhasnagar, Maharashtra, 421004, India

Location

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

• Deepa Arora, MD

  Clinexel Life Sciences Pvt. Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the Investigator and study participants will remain blinded to the treatment administered (drug or placebo) till the final results of the study are obtained. The placebo will identical to the investigational medicinal product in smell, taste, and appearance.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of the Investigational Product in Healthy Adult Volunteers

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 8, 2022
• Study Start: December 2, 2022
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)