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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers Only
• Intervention / Treatment: Drug: Placebo; Drug: 83-0060

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Greater Sydney Area
    • Sydney, Greater Sydney Area, Australia, NSW 2031
      • Scientia Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose level 1 or placebo; Dose level 1. SAD study part.	Drug: Placebo; Placebo; Drug: 83-0060; Oral MPro inhibitor
Experimental: Single dose level 2 or placebo; Dose level 2. SAD study part.	Drug: Placebo; Placebo; Drug: 83-0060; Oral MPro inhibitor
Experimental: Single dose level 3 or placebo; Dose level 3. SAD study part.	Drug: Placebo; Placebo; Drug: 83-0060; Oral MPro inhibitor
Experimental: Single dose level 4 or placebo; Dose level 4. SAD study part.	Drug: Placebo; Placebo; Drug: 83-0060; Oral MPro inhibitor
Experimental: Single dose level 5 or placebo; Dose level 5. SAD study part.	Drug: Placebo; Placebo; Drug: 83-0060; Oral MPro inhibitor
Experimental: Multiple dose level 1 or placebo; Dose level 1. MAD study part.	Drug: Placebo; Placebo; Drug: 83-0060; Oral MPro inhibitor
Experimental: Multiple dose level 2 or placebo; Dose level 2. MAD study part.	Drug: Placebo; Placebo; Drug: 83-0060; Oral MPro inhibitor
Experimental: Multiple dose level 3 or placebo; Dose level 3. MAD study part.	Drug: Placebo; Placebo; Drug: 83-0060; Oral MPro inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AEs	Incidence of Adverse Events observed during the study	8 days in SAD part, 17 days for MAD part
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
Incidence of SAEs	Incidence of Serious Adverse Events observed during the study	8 days in SAD part, 17 days for MAD part
Incidence of lab deviations	Incidence of clinically relevant deviations in the clinical laboratory parameters	8 days in SAD part, 17 days for MAD part

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration	Plasma concentration, ng/mL	8 days in SAD part, 17 days for MAD part

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamics (PD) of single and multiple oral doses of 83-0060	Serum PD endpoint	24 hours in SAD part, 11 days for MAD part

Collaborators and Investigators

• Sponsor: Traws Pharma, Inc.
• Collaborators: Trawsfynydd Therapeutics AU Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): August 9, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 83-0060-0001; CT-2024-CTN-00084-1 (Other Identifier: therapeutic goods administration)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No