COVID-19Phase 1NCT05532293
Phase One Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of MSP008-22 in Healthy Adult Volunteers
A Phase 1 study testing MSP008-22 in people with COVID-19, run by Godavari Biorefineries Limited at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- MSP008-22
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesIndia
- Study dates
- 2 Dec 2022to 10 Nov 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers will be enrolled in the study when the following inclusion criteria will be met:
- 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.
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- 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);
- If Male
- Using an effective method of contraception (condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomy) throughout the study and up to one month after the last IMP administration
Who cannot join
- 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.
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- 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.
- The volunteer has participated in more than 2 clinical studies within the 12 months prior to screening.
- The volunteer has used any investigational drug or participated in any clinical trial within 90 days prior to dosing in this study.
- The volunteer has donated or lost a significant volume of blood (>450 mL) within 4 weeks prior to the study.
- The volunteers have a history of hyperemesis
- The volunteer is unwilling to reside in the study site for the duration of the study or to cooperate fully with the investigator or site personnel.
- The volunteer has an AST/ALT or total bilirubin greater than the ULN. One repeat test will be allowed.
- The volunteer has a history of relevant atopy or drug hypersensitivity or known intolerance to the inactive ingredients in the IMP.
- The volunteer has clinically relevant abnormalities found in physical examination, vital signs measurements, laboratory safety tests or ECG, e.g. QTc according to Bazett: QTc > 450ms, PQ > 220ms, QRS > 120ms
- The volunteer has supine pulse rate not within 45 to 90 beats per minute and/or supine blood pressure Systolic < 90 >145 mmHg and diastolic < 40 > 95 mmHg.
- Surgery or trauma with significant blood loss within 2 months before the planned screening for the trial.
- Any social and medical condition that would jeopardize the volunteer's appropriate participation in this study.
- Have any medical dietary restrictions.
- Cannot communicate reliably with the Investigator(s)
- Are unlikely to co-operate with the requirements of the study.
- Known or suspected of not being able to comply with the trial protocol and/or clinical unit restrictions.
- Are unwilling or unable to give written informed consent.
- Volunteer is an employee of the Sponsor, the Investigator or the Institution of the Investigator.
- If female:
- Pregnancy or breast-feeding.
- Woman of childbearing potential not using an accepted effective contraceptive method or using oral contraceptives
- If male:
- Not using an accepted effective method of contraception.
Trial locations and contacts
2 sites in 1 country.
India2 sites
K. J. Somaiya Hospital & Research Centre, Somaiya Ayurvihar Complex, Eastern Express Highway, Sion East
Mumbai, Maharashtra, 400022
Ashirwad Hospital & Research Centre, Maratha Section, Near Jijamata Udyan, Ulhasnagar, Maharashtra, India
Ulhasnagar, Maharashtra, 421004
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of MSP008-22 in Healthy Adult Volunteers
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.
Read the detailed description
MSP008-22 is a New Chemical Entity (NCE) that has demonstrated positive outcomes during in vitro and in vivo studies for COVID19.
This clinical study is planned as a double blind, randomised, placebo-controlled, combined clinical study of two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies, respectively. Pharmacokinetic (PK) profile of the MSP008-22 will also be assessed in both parts of the study. The safety, tolerability and pharmacokinetic data and results obtained from this study will determine the potentially efficacious doses of the IMP (MSP008-22) in the subsequent efficacy studies in COVID-19 patients.
The SAD Part will consist of 6 cohorts of 8 healthy adult volunteers, each volunteer will be randomly (blinded) allocated to MSP008-22 or placebo (each cohort will consist of 6 volunteers receiving MSP008-22 and 2 volunteers receiving placebo). Six (6) dose levels (200 (OD), 400(OD), 400(BD), 600(BD), 800(BD) and 1000 (BD) mg) of MSP008-22 are selected for oral administration. An additional cohort of 8 volunteers (6:2 MSP008-22 vs placebo) of lower doses of MSP008-22 (less than 1000 mg BD) may be recruited into the SAD Part, if required.
The MAD Part will consist of 2 cohorts of 8 healthy adult volunteers, each volunteer will be randomly (blinded) allocated to MSP008-22 or placebo (each cohort will consist of 6 volunteers receiving MSP008-22 and 2 volunteers receiving placebo). Two (2) dose levels (800(BD) and 1000(BD) mg) of the MSP008-22 are selected for oral administration.
An additional cohort of 8 volunteers (6:2 MSP008-22 vs placebo) of lower doses of MSP008-22 (less than 1000 mg BD) may be recruited into the MAD Part, if required.
Healthy adult volunteers eligible for participations in the study will be enrolled as study participants. They will be randomly assigned to the study drug (MSP008-22) and placebo arm during both the SAD and MAD parts of the study.
A total of eighty (80) healthy adult volunteers volunteer (48 in the 06 cohorts of SAD part and 16 in the 02 cohorts of MAD part, and 16 subjects of the 02 additional cohorts in either SAD or MAD part of the study, if required) are planned to be enrolled and randomized in the study.
Between each cohort, an interim analysis of PK, safety and tolerability will be performed. An independent Drug Safety Monitoring Board (DSMB) will provide recommendations about stopping, modifying or continuing the study. Decision to escalate to next higher dose level/ Ccohort will be based on interim analysis of pharmacokinetic data, safety data at 36-hr post-dose, as well as during the safety follow-up of 30-days post dose. Once a particular dose level is judged to be safe by the DSMB, the study will proceed and doses administered to the study subjects will escalate to the next higher dose level/ cohort.
The dosing and the conduct of study between the cohorts will be staggered by approximately 2 to 4 weeks.
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.
Safety evaluation during both the SAD \& MAD pars of the clinical study will include adverse events, clinical laboratory/ pathological test results, electrocardiogram (ECG), and measurement of vital signs.
Blood samples for pharmacokinetic profiling of MSP008-22 will be collected as follows:
- for the first 04 dose cohorts of the SAD Part of the Study - at pre-dose (30 min prior to dosing), and at 1h, 2h, 4h, 8h, 12h, and 24h, and 36 h.
- for the last 02 dose cohorts of the SAD Part of the Study - at pre-dose (30 min prior to dosing), and at 1h, 1.5h, 2h, 3h, 4h, 8h, 12h (pre dose for 2nd dose (approx. 02 mins prior to 2nd dose)), 14h, 16h, 18h, 24.00, and 36h.
- for Day 1 of MAD part of the Study - at pre-dose (30 min prior to dosing), 1h, 1.5h, 2h, 3h, 4h, 8h, 12h (pre dose for 2ndpre dose (approx. 02 mins prior to 2nd dose)), 14h, 16h, 18h, and 24h (pre dose for 1st dose for Day 2 (approx. 02 mins prior to Day-2-1st dose)).
- For Day 2 of MAD part of the Study - sample collected at 24h after Day 1-1st dose will be serve the purpose of pre-dose sample for Day 2 1st dose).
- For Days 3 - 6 of MAD part of the Study - at pre-dose (30 mins prior to dosing of 1st dose/ morning dose).
- for Day 7 of MAD part of the Study - at pre-dose (30 min prior to dosing), 1h, 1.5h, 2h, 3h, 4h, 8h, 12h (pre dose for 2nd dose (approx. 02 mins prior to 2nd dose)), 14h, 16h, 18h, 24h and 36h.
- Conditions
- COVID-19
- Being tested
- MSP008-22, Placebo
- Keywords
- Single Ascending Dose, Phase 1, Multiple Ascending Dose, randomised, double blind, MSP008-22, healthy volunteers, COVID-19, safety, tolerability, pharmacokinetics
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSP008-22Drug
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.
PlaceboOther
Placebo tablets identical in appearance, taste and smell to the tablets of MSP008-22
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: MSP008-22 |
| Placebo | Placebo comparator | placebo will be identical in smell, taste, and appearance to the tablets of MSP008-22 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events [Time Frame- ]
To assess safety \& tolerability of MSP008-22 in Human
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 7 days post last dose for each cohort
Secondary outcomes (10)
Plasma Cmax
Maximum plasma concentrations
Measured: post-dose in Single ascending Dose trial & post dose on days 1 & 7 in Multiple ascending dose part of the trial
Plasma Tmax
Time to Maximum plasma concentrations (tmax)
Measured: post-dose in Single ascending Dose trial & post dose on days 1 & 7 in Multiple ascending dose part of the trial
Plasma AUC0-t
Area under the concentration-time curve from dosing (time 0) to time t [AUC0-t]
Measured: Single ascending Dose
Plasma AUC0-inf
Area under the concentration-time curve from dosing (time 0) extrapolated to infinite time [AUC 0-inf]
Measured: Single ascending Dose
Plasma AUC0-tau
Area under the concentration-time curve to the end of the dosing period [AUC 0-tau]
Measured: post dose on days 1 & 7 in Multiple ascending dose part of the trial
Plasma AUC0-t
Area under the concentration-time curve from dosing (time 0) to time t [AUC0-t]
Measured: post dose on day 7 in Multiple ascending dose part of the trial
Plasma Kel
Elimination constant [Kel]
Measured: in Single ascending Dose trial & post-dose on day 7 in Multiple ascending dose part of the trial
Plasma t1/2
Elimination half life [t1/2]
Measured: in Single ascending Dose trial & post dose on day 7 in Multiple ascending dose part of the trial
Plasma Ctrough
Pre-dose plasma trough concentration (Ctrough)
Measured: on days 2 & 6 in Multiple ascending dose part of the trial
Plasma Racc
Accumulation ratio Racc (Cmax on Day 7/Cmax on Day 1), (AUC0-τ on Day 7/AUC0-τ on Day 1) and (Ctrough on Day 7/Ctrough on Day 1)
Measured: post dose on days 1 & 7 in Multiple ascending dose part of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start2 Dec 2022
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Godavari Biorefineries Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deepa Arora, MD, Study director, Clinexel Life Sciences Pvt. Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532293
- Sponsor's protocol ID
- Clinexel-GBL-003
- Other IDs
- CTRI/2022/08/045056
- Status last verified
- Jan 2026
- First submitted
- 5 Sep 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of MSP008-22 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05532293
- Acronym / sponsor ID
- Clinexel-GBL-003
- Conditions
- COVID-19
- Keywords
- Single Ascending Dose, Phase 1, Multiple Ascending Dose, randomised, double blind, MSP008-22, healthy volunteers, COVID-19, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Godavari Biorefineries LimitedUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
MSP008-22 is a New Chemical Entity (NCE) that has demonstrated positive outcomes during in vitro and in vivo studies for COVID19.
This clinical study is planned as a double blind, randomised, placebo-controlled, combined clinical study of two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies, respectively. Pharmacokinetic (PK) profile of the MSP008-22 will also be assessed in both parts of the study. The safety, tolerability and pharmacokinetic data and results obtained from this study will determine the potentially efficacious doses of the IMP (MSP008-22) in the subsequent efficacy studies in COVID-19 patients.
The SAD Part will consist of 6 cohorts of 8 healthy adult volunteers, each volunteer will be randomly (blinded) allocated to MSP008-22 or placebo (each cohort will consist of 6 volunteers receiving MSP008-22 and 2 volunteers receiving placebo). Six (6) dose levels (200 (OD), 400(OD), 400(BD), 600(BD), 800(BD) and 1000 (BD) mg) of MSP008-22 are selected for oral administration. An additional cohort of 8 volunteers (6:2 MSP008-22 vs placebo) of lower doses of MSP008-22 (less than 1000 mg BD) may be recruited into the SAD Part, if required.
The MAD Part will consist of 2 cohorts of 8 healthy adult volunteers, each volunteer will be randomly (blinded) allocated to MSP008-22 or placebo (each cohort will consist of 6 volunteers receiving MSP008-22 and 2 volunteers receiving placebo). Two (2) dose levels (800(BD) and 1000(BD) mg) of the MSP008-22 are selected for oral administration.
An additional cohort of 8 volunteers (6:2 MSP008-22 vs placebo) of lower doses of MSP008-22 (less than 1000 mg BD) may be recruited into the MAD Part, if required.
Healthy adult volunteers eligible for participations in the study will be enrolled as study participants. They will be randomly assigned to the study drug (MSP008-22) and placebo arm during both the SAD and MAD parts of the study.
A total of eighty (80) healthy adult volunteers volunteer (48 in the 06 cohorts of SAD part and 16 in the 02 cohorts of MAD part, and 16 subjects of the 02 additional cohorts in either SAD or MAD part of the study, if required) are planned to be enrolled and randomized in the study.
Between each cohort, an interim analysis of PK, safety and tolerability will be performed. An independent Drug Safety Monitoring Board (DSMB) will provide recommendations about stopping, modifying or continuing the study. Decision to escalate to next higher dose level/ Ccohort will be based on interim analysis of pharmacokinetic data, safety data at 36-hr post-dose, as well as during the safety follow-up of 30-days post dose. Once a particular dose level is judged to be safe by the DSMB, the study will proceed and doses administered to the study subjects will escalate to the next higher dose level/ cohort.
The dosing and the conduct of study between the cohorts will be staggered by approximately 2 to 4 weeks.
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.
Safety evaluation during both the SAD \& MAD pars of the clinical study will include adverse events, clinical laboratory/ pathological test results, electrocardiogram (ECG), and measurement of vital signs.
Blood samples for pharmacokinetic profiling of MSP008-22 will be collected as follows:
- for the first 04 dose cohorts of the SAD Part of the Study - at pre-dose (30 min prior to dosing), and at 1h, 2h, 4h, 8h, 12h, and 24h, and 36 h.
- for the last 02 dose cohorts of the SAD Part of the Study - at pre-dose (30 min prior to dosing), and at 1h, 1.5h, 2h, 3h, 4h, 8h, 12h (pre dose for 2nd dose (approx. 02 mins prior to 2nd dose)), 14h, 16h, 18h, 24.00, and 36h.
- for Day 1 of MAD part of the Study - at pre-dose (30 min prior to dosing), 1h, 1.5h, 2h, 3h, 4h, 8h, 12h (pre dose for 2ndpre dose (approx. 02 mins prior to 2nd dose)), 14h, 16h, 18h, and 24h (pre dose for 1st dose for Day 2 (approx. 02 mins prior to Day-2-1st dose)).
- For Day 2 of MAD part of the Study - sample collected at 24h after Day 1-1st dose will be serve the purpose of pre-dose sample for Day 2 1st dose).
- For Days 3 - 6 of MAD part of the Study - at pre-dose (30 mins prior to dosing of 1st dose/ morning dose).
- for Day 7 of MAD part of the Study - at pre-dose (30 min prior to dosing), 1h, 1.5h, 2h, 3h, 4h, 8h, 12h (pre dose for 2nd dose (approx. 02 mins prior to 2nd dose)), 14h, 16h, 18h, 24h and 36h.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| MSP008-22 | Experimental | Drug: MSP008-22MSP008-22 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. |
| Placebo | Placebo comparator | Other: Placeboplacebo will be identical in smell, taste, and appearance to the tablets of MSP008-22 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Volunteers will be enrolled in the study when the following inclusion criteria will be met:
- 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.
Key exclusion criteria (37 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSP008-22MSP008-22 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. | Drug | MSP008-22 |
| PlaceboPlacebo tablets identical in appearance, taste and smell to the tablets of MSP008-22 | Other | Placebo |
Primary outcome
Number of participants with adverse events [Time Frame- ]
Time frame: 30 days post last dose for each cohort
To assess safety \& tolerability of MSP008-22 in Human
Incidence of serious adverse events (SAEs) by relation to the IMP (related/not related)
Time frame: 30 days post last dose for each cohort
To assess safety \& tolerability of MSP008-22 in Human
Percentage of volunteers who experience at least 1 Treatment Emergent Adverse Event (TEAE)
Time frame: 30 days post last dose for each cohort
To assess safety \& tolerability of MSP008-22 in Human
Percentage of volunteers who discontinue due to an Adverse Event (AE).
Time frame: 30 days post last dose for each cohort
To assess safety \& tolerability of MSP008-22 in Human
Percentage of volunteers who meet the markedly abnormal criteria for safety laboratory tests at least once post dose.
Time frame: 7 days post last dose for each cohort
To assess safety MSP008-22 in Human
Percentage of volunteers who meet the markedly abnormal criteria for vital sign measurements at least once post dose
Time frame: 7 days post last dose for each cohort
To assess safety MSP008-22 in Human
Percentage of volunteers who meet the markedly abnormal criteria for safety electrocardiogram (ECG) parameters at least once post dose.
Time frame: 7 days post last dose for each cohort
To assess safety MSP008-22 in Human
10 secondary outcomes
Plasma Cmax
Time frame: post-dose in Single ascending Dose trial & post dose on days 1 & 7 in Multiple ascending dose part of the trial
Plasma Tmax
Time frame: post-dose in Single ascending Dose trial & post dose on days 1 & 7 in Multiple ascending dose part of the trial
Plasma AUC0-t
Time frame: Single ascending Dose
Plasma AUC0-inf
Time frame: Single ascending Dose
Plasma AUC0-tau
Time frame: post dose on days 1 & 7 in Multiple ascending dose part of the trial
Plasma AUC0-t
Time frame: post dose on day 7 in Multiple ascending dose part of the trial
Plasma Kel
Time frame: in Single ascending Dose trial & post-dose on day 7 in Multiple ascending dose part of the trial
Plasma t1/2
Time frame: in Single ascending Dose trial & post dose on day 7 in Multiple ascending dose part of the trial
Plasma Ctrough
Time frame: on days 2 & 6 in Multiple ascending dose part of the trial
Plasma Racc
Time frame: post dose on days 1 & 7 in Multiple ascending dose part of the trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepa Arora, MD study director
Clinexel Life Sciences Pvt. Limited
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSP008-22 in people with COVID-19, run by Godavari Biorefineries Limited at 2 sites in India.
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 18 inclusion and 37 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 3 Feb 2026. 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 India. 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. Some participants in this study may receive a placebo. 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?
Number of participants with adverse events [Time Frame- ] (time frame: 30 days post last dose for each cohort). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2026.