Phase One Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of MSP008-22 in Healthy Adult Volunteers
NCT05532293 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2026-02-03
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
Interventions
- DRUG
-
MSP008-22
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.
- OTHER
-
Placebo
Placebo tablets identical in appearance, taste and smell to the tablets of MSP008-22
Sponsors & Collaborators
-
Godavari Biorefineries Limited
lead OTHER
Principal Investigators
-
Deepa Arora, MD · Clinexel Life Sciences Pvt. Limited
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-12-02
- Primary Completion
- 2025-11-10
- Completion
- 2025-11-10
Countries
- India
Study Locations
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