Evaluation Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volunteers

Healthy Volunteers Only Clinical Trial

Official title:

A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered 83-0060 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06402136
• Other study ID #: 83-0060-0001
• Secondary ID: CT-2024-CTN-0008
• Status: Recruiting
• Phase: Phase 1
• Start date: April 15, 2024
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Traws Pharma, Inc.
• Contact: Ekaterina Dokukina, MD, MPHIL
• Phone: +382069728309
• Email: kdokukina[@]chemdiv.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of 83-0060 in Healthy Volunteers

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 2 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers Only

Intervention

Drug:
• 83-0060
Oral MPro inhibitor
• Placebo
Placebo

Locations

Country	Name	City	State
Australia	Scientia Clinical Research	Sydney	Greater Sydney Area

Sponsors (1)

Lead Sponsor	Collaborator
Traws Pharma, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration	Plasma concentration, ng/mL	72 hours for SAD, 10 days for MAD
Secondary	Incidence of AEs	Incidence of Adverse Events observed during the study	8 days in SAD part, 17 days for MAD part
Secondary	Incidence of drug-related AEs	Incidence of Adverse Events observed during the study deemed related to the study drug by the Investigator	8 days in SAD part, 17 days for MAD part
Secondary	Incidence of SAEs	Incidence of Serious Adverse Events observed during the study	8 days in SAD part, 17 days for MAD part
Secondary	Incidence of lab deviations	Incidence of clinically relevant deviations in the clinical laboratory parameters	8 days in SAD part, 17 days for MAD part