Healthy Volunteers Only
Conditions
Brief summary
This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of 83-0060 in Healthy Volunteers
Detailed description
This is a Phase 1, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD of orally administered 83-0060 in Healthy Volunteers. The study will be conducted in 2 parts: a single ascending dose (SAD) part at up to 5 dose levels and a multiple ascending dose (MAD) part at up to 3 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence.
Interventions
DRUG83-0060
Oral MPro inhibitor
DRUGPlacebo
Placebo
Sponsors
Traws Pharma, Inc.
Trawsfynydd Therapeutics AU Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-Blind, Placebo-Controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 2. Adult males and females, 18 to 65 years of age (inclusive) at screening. 3. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening.
Exclusion criteria
1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant. 2. History of surgery or hospitalisation within 30 days prior to screening, or surgery planned during the study. 3. Acute infections within 4 weeks prior to screening or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications. 4. Presence or history of any abnormality or illness, including gastrointestinal surgery, which in the opinion of the PI may affect absorption, distribution, metabolism or elimination of the study drug. 5. Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma). 6. Any screening laboratory result outside the normal laboratory reference range (as confirmed upon repeated testing) and deemed clinically significant by the PI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of drug-related AEs | 8 days in SAD part, 17 days for MAD part | Incidence of Adverse Events observed during the study deemed related to the study drug by the Investigator |
| Incidence of SAEs | 8 days in SAD part, 17 days for MAD part | Incidence of Serious Adverse Events observed during the study |
| Incidence of lab deviations | 8 days in SAD part, 17 days for MAD part | Incidence of clinically relevant deviations in the clinical laboratory parameters |
| Incidence of AEs | 8 days in SAD part, 17 days for MAD part | Incidence of Adverse Events observed during the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration | 8 days in SAD part, 17 days for MAD part | Plasma concentration, ng/mL |
Countries
Australia
Outcome results
None listed