Study for safety & pharmacokinetics of WP1122 in healthy volunteers [COVID-19]
Research type
Research Study
Full title
A Phase 1a, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Overlapping Single and Multiple Ascending Dose Escalation Study of WP1122 to Establish Maximum Tolerated Dose and Evaluate Pharmacokinetics
IRAS ID
301139
Contact name
Dave Singh
Contact email
Sponsor organisation
Moleculin Biotech
Eudract number
2021-001435-70
Duration of Study in the UK
0 years, 2 months, 0 days
Research summary
The Sponsor, Moleculin Biotech, is developing a new experimental study medication called WP1122. WP1122 has the potential to stop virus replication, which can cause worsening of disease, hence this drug may be beneficial in the treatment of patients with SARS-CoV-2 (the virus that causes COVID-19).
The purpose of this research study is to determine whether the study drug, WP1122, is safe and well tolerated in healthy participants before it is potentially given to patients in further studies.
WP1122 is an investigational medication; “investigational” means the medicine is not yet licensed to be available on prescription and is still being tested. However, this study has been approved by the MHRA and an ethics committee to make sure it is properly designed and ethically justifiable.
Lay summary of study results:
The present study wanted to find the maximum tolerated dose (or non-toxic dose) of study prodrug WP1122. Prodrugs are drugs' precursors or substances that once taken, are transformed by the body in drugs. Study also wanted to dig into pharmacokinetics of this substance (the way a drug is absorbed, distributed, transformed and excreted by the human body).Results showed that WP1122 administered orally is rapidly converted to 2-DG drug and delivers 2-DG in a dose dependent manner.
The maximum tolerated dose was determined as 16 mg/kg q12h (32 mg/kg/day) for 7 days. Doses below 32 mg/kg/day were also found to be safe and tolerable.REC name
London - Riverside Research Ethics Committee
REC reference
21/HRA/3728
Date of REC Opinion
14 Oct 2021
REC opinion
Further Information Favourable Opinion